Identity
- Trade Name
- Butrex Buttress Plating System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Plate Holder, ButreX System FDA UDI
- Model / Reference
- X023-0100 FDA UDI
- Description
- Plate Holder, ButreX System FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X02301001 FDA UDI
- FDA Product Code
- HTC FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Butrex Buttress Plating System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI e2d3b3e6-ab6e-4c94-837b-fe3f62746a84 35 fields · synced Jun 1, 2026