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CoLink®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P40 ST235Ref P40 ST023Ref P40 ST014Ref P40 ST145Ref P40 ST021Ref P40 ST237Ref P40 ST015Ref P40 ST165Ref P40 ST055Ref P40 ST013
Identity
- Trade Name
- CoLink® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- CoLink Plating System EUDAMEDPlate/Screw Fixation System FDA UDI
- Model / Reference
- P40 ST235 EUDAMEDFDA UDIP40 ST023 EUDAMEDFDA UDIP40 ST014 EUDAMEDFDA UDIP40 ST145 EUDAMEDFDA UDIP40 ST021 EUDAMEDFDA UDIP40 ST237 EUDAMEDFDA UDIP40 ST015 EUDAMEDFDA UDIP40 ST165 EUDAMEDFDA UDIP40 ST055 EUDAMEDFDA UDIP40 ST013 EUDAMEDFDA UDI
- Description
- Plate/Screw Fixation System FDA UDI
Identifiers
- Catalog Number
- P40 ST023 FDA UDIP40 ST165 FDA UDIP40 ST014 FDA UDIP40 ST015 FDA UDIP40 ST055 FDA UDIP40 ST013 FDA UDIP40 ST237 FDA UDIP40 ST145 FDA UDIP40 ST021 FDA UDIP40 ST235 FDA UDI
- Primary DI / UDI-DI
- 00817906020410 EUDAMEDFDA UDI00817906020267 EUDAMEDFDA UDI00817906020212 EUDAMEDFDA UDI00817906020427 EUDAMEDFDA UDI00817906020243 EUDAMEDFDA UDI00817906020328 EUDAMEDFDA UDI00817906020229 EUDAMEDFDA UDI00817906020465 EUDAMEDFDA UDI00817906020489 EUDAMEDFDA UDI00817906020205 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817906020410 EUDAMEDB-00817906020267 EUDAMEDB-00817906020212 EUDAMEDB-00817906020427 EUDAMEDB-00817906020243 EUDAMEDB-00817906020328 EUDAMEDB-00817906020229 EUDAMEDB-00817906020465 EUDAMEDB-00817906020489 EUDAMEDB-00817906020205 EUDAMED
- 510(k) Number
- K163293 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CoLink® by In2Bones, USA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817906020410 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (30)
- EUDAMED 6d243041-140a-4216-a4ab-0fc1a3c27942 61 fields · synced Sep 17, 2026
- EUDAMED 516d134a-952c-4027-82c2-1487b0087055 61 fields · synced May 16, 2026
- EUDAMED 8f1e51dd-d733-498b-844b-add2834a57ca 61 fields · synced May 16, 2026
- EUDAMED f249b5f1-adce-4b16-beee-b17de96b60e8 61 fields · synced May 17, 2026
- EUDAMED ef6746c6-8f9e-4897-8c33-f18b70dfe596 61 fields · synced May 18, 2026
- EUDAMED 2664b1a4-91c1-4fe3-9d8b-25baeffebbb9 61 fields · synced May 18, 2026
- EUDAMED 9a3d844f-a5d5-4191-a77f-798cdb1950a0 61 fields · synced May 18, 2026
- EUDAMED d52d3e4e-f410-4fd3-9b6c-9c956acc1a41 61 fields · synced May 18, 2026
- EUDAMED cd173b52-7ff0-48cd-8c24-fc099851592a 61 fields · synced May 18, 2026
- EUDAMED 54e5fed5-7465-4576-91ff-0690fcd005ec 61 fields · synced May 18, 2026
- FDA UDI a133037f-b7a3-4fc6-a092-c6fc090b054f 37 fields · synced May 29, 2026
- FDA UDI b94381ed-0e1d-40cd-b6b8-aff28eccac2f 37 fields · synced May 29, 2026
- FDA UDI a7e390a0-ffeb-481e-ae83-03b51adbf274 37 fields · synced May 29, 2026
- FDA UDI e6bf8397-dd5d-4a48-9337-f37aedc0ddea 37 fields · synced May 30, 2026
- FDA UDI fb1d878c-3255-40be-8c55-182c318f47e4 37 fields · synced May 30, 2026
- FDA UDI d4a69e05-d66c-4588-b0ce-ad4a20dcf806 37 fields · synced May 30, 2026
- FDA UDI 686a3592-d0e5-4c4c-8211-5a2517b51caa 37 fields · synced May 30, 2026
- FDA UDI 605234d1-ac5a-421d-ab11-555b0aee562f 37 fields · synced May 30, 2026
- FDA UDI a1dc4419-aedc-4c9c-89bd-176d400d199e 37 fields · synced May 30, 2026
- FDA UDI 87fd3ace-e3b9-4faa-9e9d-1853f9a51072 37 fields · synced May 30, 2026
- EUDAMED 027149f9-271a-45d7-83ac-89a28605cbb8 61 fields · synced Jul 9, 2026
- EUDAMED 699bc585-dfc9-4624-9702-e99c29a7a06b 61 fields · synced Jul 9, 2026
- EUDAMED f2256482-3955-4ea5-bf8d-5bd5836d1445 61 fields · synced Jul 10, 2026
- EUDAMED 08782daa-950e-46b6-96ee-1dad67cfadb9 61 fields · synced Jul 10, 2026
- EUDAMED 94d9ad71-0f74-4db8-a87e-6398a62551e8 61 fields · synced Jul 14, 2026
- EUDAMED be604e56-08d8-485f-8832-bc92ee1dd81a 61 fields · synced Jul 15, 2026
- EUDAMED 10dd790d-2717-4469-a39d-fe76bc22b687 61 fields · synced Jul 15, 2026
- EUDAMED 5b86898f-3ba6-4374-abb4-519013d3098d 61 fields · synced Jul 19, 2026
- EUDAMED eeaf18eb-d2f9-4b0e-af5e-5cfbf58a4f41 61 fields · synced Jul 22, 2026
- EUDAMED c7574da4-4576-45d7-89b3-6f037fe4fc76 61 fields · synced Sep 17, 2026