Identity
- Trade Name
- CAVUX Facet Fixation System, 4mm FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Device Name
- CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FDA UDI
- Model / Reference
- DX-31-403 FDA UDI
- Description
- CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852776006591 FDA UDI
- 510(k) Number
- K220951 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Implantable cervical facet joint distractor FDA UDI
Classification
- Device Class
- U 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
Category: Implantable cervical facet joint distractor
CAVUX Facet Fixation System, 4mm by Providence Medical Technology, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220951 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Providence Medical Technology, Inc.
Sources (1)
- FDA UDI 7c6511ca-a208-4476-b7a0-484411fd7833 34 fields · synced May 31, 2026