Updated 22 October 2026
Orthopaedic and spine device distributors in Spain: 25 licensed establishments
The Bastion Hale Distributor Index lists 25 establishments in Spain whose registry records include orthopaedics, spine and trauma: 16 with a channel role (importer, distributor, wholesaler or authorised representative), 4 registration holders without a channel role, and 5 registered as manufacturer or exporter only, out of 1,855 medical device establishments in Spain overall. The records come from EUDAMED, web, US FDA (openFDA) and Health Canada, last seen on 23 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 15 | 60% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 5 | 20% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 24% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 12 | 48% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 16% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Spain
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
Top 20 orthopaedics, spine and trauma establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Miñano | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +6 more | 192 | 28 | 0 | 63.1 | 3/5 |
| 2 | AVINENT IMPLANT SYSTEM, S.L.U. Santpedor, Barcelona | Channel Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more | 50 | 4 | 0 | 48.1 | 3/5 |
| 3 | AJL OPHTHALMIC, S.A. VITORIA GASTEIZ | Channel Importer, Authorised representative, Manufacturer | Anaesthesia and respiratory, Ophthalmic, Orthopaedics, spine and trauma | 3 | 1 | 0 | 27.2 | 3/5 |
| 4 | Valdent S.L. CASTELLÓN | Channel Importer, Authorised representative | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 18 | 26.6 | 4/5 |
| 5 | ANCLADEN SL BARCELONA | Channel Importer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 7 | 21.0 | 4/5 |
| 6 | Klockner, S.L. Madrid | Channel Importer, Authorised representative | General hospital and consumables, Dental, Patient monitoring and neurology +2 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 7 | Advita Ortho Iberica SLU LLanera | Channel Importer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 2 | 17.3 | 4/5 |
| 8 | ASF GESTION, SL LEGANES | Channel Importer | Aesthetics, dermatology and lasers, Ear, nose and throat, Patient monitoring and neurology +1 more | 0 | 0 | 2 | 17.3 | 4/5 |
| 9 | Biomedx Innovations, S.L.U Madrid | Channel Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 1 | 15.7 | 4/5 |
| 10 | PRODUCTO SANITARIO INGENIERÍA Y CONSULTORÍA, S.L. MOSTOLES | Channel Importer, Authorised representative | Orthopaedics, spine and trauma | 0 | 0 | 0 | 15.3 | 3/5 |
| 11 | A2C SUMINISTROS HOSPITALARIOS, S.L MOLINS DE REI | Channel Importer | Orthopaedics, spine and trauma | 0 | 0 | 0 | 13.1 | 3/5 |
| 12 | Acumed Iberica Madrid | Channel Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 13.1 | 3/5 |
| 13 | ADEENE INVEST SLU Barcelona | Channel Importer | Anaesthesia and respiratory, Orthopaedics, spine and trauma | 0 | 0 | 0 | 13.1 | 3/5 |
| 14 | ASESORÍA DE CONSUMO Y SANIDAD S.L. Sotogrande | Channel Authorised representative | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +2 more | 0 | 0 | 0 | 13.1 | 3/5 |
| 15 | AST Vision Care SL MADRID | Channel Importer | Ophthalmic, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 13.1 | 3/5 |
| 16 | BESTMEDIC ZARAGOZA | Channel Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 0 | 13.1 | 3/5 |
| 17 | TERRATS MEDICAL, S.L. Barbera del Valles. | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma | 569 | 3 | 0 | 56.4 | 3/5 |
| 18 | IMPLANT PROTESIS DENTAL 2004, S.L. Premià de Dalt, Barcelona | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 111 | 3 | 0 | 49.8 | 4/5 |
| 19 | CERAROOT S.L. Les Franqueses del Vallès | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 3 | 0 | 37.0 | 4/5 |
| 20 | Neos Surgery, S.L. Cerdanyola del Valles | Holder Registration holder, Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 4 | 2 | 0 | 31.1 | 4/5 |
Questions about orthopaedics, spine and trauma distributors in Spain
How many orthopaedics, spine and trauma distributors are there in Spain?
The Index counts 25 establishments in Spain with orthopaedics, spine and trauma in their registry record, of which 16 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, web, US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in Spain?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a orthopaedics, spine and trauma distributor in Spain?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Spain to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a orthopaedics, spine and trauma distributor in Spain?
A company that appears in a public regulatory registry with an address in Spain and whose linked device listings fall in the orthopaedics, spine and trauma segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Spain
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 22 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- web (public register): 13 establishments, last seen 23 October 2026. Public register.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 12 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.