Identity
- Trade Name
- coflex Interlaminar Technology, 16mm FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable FDA UDI
- Model / Reference
- UPI00016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260148898495 FDA UDI
- PMA Number
- P110008 FDA UDI
- FDA Product Code
- NQO FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
MR Conditional FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable
coflex Interlaminar Technology, 16mm by Paradigm Spine, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable.
- Innovasis® Cranial System — Innovasis, Inc. · Class II
- Innovasis® Cranial System — Innovasis, Inc. · Class II
- coflex Interlaminar Technology, 8mm — Paradigm Spine, LLC · Class III
- coflex Interlaminar Technology, 12mm — Paradigm Spine, LLC · Class III
- coflex Interlaminar Technology, 14mm — Paradigm Spine, LLC · Class III
- coflex Interlaminar Technology, 16mm — Paradigm Spine, LLC · Class III
- coflex Interlaminar Technology, 12mm — Paradigm Spine, LLC · Class III
- coflex Interlaminar Technology, 10mm — Paradigm Spine, LLC · Class III
Cleared under the same submission
P110008 also covers:
- coflex Interlaminar Technology, 10mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 10mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 12mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 12mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 14mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 16mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 8mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, 8mm — Paradigm Spine, LLC
- coflex Interlaminar Technology, US, Size 14 — Paradigm Spine, LLC
- coflex Trial with wings, 8mm — Paradigm Spine, LLC
- coflex Trial, 16mm — Paradigm Spine, LLC
- coflex Trial, 8mm — Paradigm Spine, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Paradigm Spine, LLC
Sources (1)
- FDA UDI 0170eca5-257f-4c54-acde-d870a01078ba 33 fields · synced Jun 8, 2026