Identity
- Trade Name
- coflex-F™ System 10mm FDA UDI
- Generic Name
- Lumbar decompression interspinous spacer FDA UDI
- Model / Reference
- RPI00010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260148897481 FDA UDI
- 510(k) Number
- K093438 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Lumbar decompression interspinous spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Lumbar decompression interspinous spacer
coflex-F™ System 10mm by Paradigm Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar decompression interspinous spacer.
- Affix — Nuvasive, Inc. · Class II
- Affix — Nuvasive, Inc. · Class II
- Affix — Nuvasive, Inc. · Class II
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- InterBRIDGE — Ldr Spine USA · Class II
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- InterBRIDGE — Ldr Spine USA · Class II
- Superion™ — Boston Scientific Neuromodulation · Class III
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, 12mm — Paradigm Spine, LLC
- coflex-F trial, 16mm — 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 (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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paradigm Spine, LLC
Sources (1)
- FDA UDI e220497f-9bc5-489e-a150-b6dbd73d9b6f 33 fields · synced May 30, 2026