Identity
- Trade Name
- DTRAX Bone Screw FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Device Name
- The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device. FDA UDI
- Model / Reference
- PD-32-301 FDA UDI
- Description
- The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device. FDA UDI
Identifiers
- Catalog Number
- PD-32-301 FDA UDI
- Primary DI / UDI-DI
- 10852776006024 FDA UDI
- 510(k) Number
- K121713 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Implantable cervical facet joint distractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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 Bone Screw by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Providence Medical Technology, Inc.
Sources (1)
- FDA UDI 808faf7b-31be-44e3-9ed9-d7749ab08131 36 fields · synced May 30, 2026