Identity
- Trade Name
- CoFix™ EUDAMEDcoflex-F trial, 12mm FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- coflex-F™ trial, 12mm EUDAMED
- Model / Reference
- RCT00012 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260148890291 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260148890291 EUDAMED
- 510(k) Number
- K093438 FDA UDI
- FDA Product Code
- KWP FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
coflex-F trial, 12mm by Paradigm Spine, LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K093438 also covers:
- coflex-F Punching Pliers — Paradigm Spine, LLC
- coflex-F Punching Pliers replacement inserts — Paradigm Spine, LLC
- coflex-F Punching Pliers replacement inserts — Paradigm Spine, LLC
- coflex-F trial with X-ray marker, Size 8 — Paradigm Spine, LLC
- coflex-F trial, 10mm — Paradigm Spine, LLC
- coflex-F trial, 16mm — Paradigm Spine, LLC
- coflex-F™ System 10mm — Paradigm Spine, LLC
- coflex-F™ System 12mm — Paradigm Spine, LLC
- coflex-F™ System 14mm — Paradigm Spine, LLC
- coflex-F™ System 16mm — Paradigm Spine, LLC
- coflex-F™ system, 8mm — Paradigm Spine, LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paradigm Spine, LLC
Sources (2)
- FDA UDI 17bc568b-4c07-4255-956c-4e1559a7b291 33 fields · synced Jun 18, 2026
- EUDAMED 060a54ae-8001-4bf3-95f9-1c2629bf0546 61 fields · synced Jun 18, 2026