Identity
- Trade Name
- CAVUX CERVICAL CAGE-X, 5MM FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Device Name
- CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V Titanium). The implants are single-use only. FDA UDI
- Model / Reference
- PD-31-204 FDA UDI
- Description
- CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V Titanium). The implants are single-use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852776006447 FDA UDI
- 510(k) Number
- K122801 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Implantable cervical facet joint distractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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 Cervical Cage-X, 5mm by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K122801 also covers:
- CAVUX Cage-LX, 4mm — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- CAVUX Cervical Cage-B — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- CAVUX Cervical Cage-T — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- CAVUX Cervical Cage-X — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- CAVUX™ Cervical Cage SB — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- CAVUX™ Cervical Cage-B 5mm — PROVIDENCE MEDICAL TECHNOLOGY, INC.
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 |
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Manufacturer
- Manufacturer
- Providence Medical Technology, Inc.
Sources (1)
- FDA UDI ff0cc818-4cee-4540-845c-78fd59726b72 34 fields · synced May 30, 2026