Identity
- Trade Name
- DTRAX Cervical Cage-T FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Device Name
- The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level. FDA UDI
- Model / Reference
- PD-31-100 FDA UDI
- Description
- The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level. FDA UDI
Identifiers
- Catalog Number
- PD-31-100 FDA UDI
- Primary DI / UDI-DI
- 10852776006017 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
- Not 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
Yes
FDA UDI
Radiation Sterilization FDA UDI
DTRAX Cervical Cage-T by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122801 also covers:
- CAVUX CERVICAL CAGE-X, 5MM — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- 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 2952b274-3a55-4a98-9e88-e47fcf0a4bba 36 fields · synced May 30, 2026