Identity
- Trade Name
- T-15 Driver and Hole Punch FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- XM-216-0015 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064XM21600151 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
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
Radiation Sterilization FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
T-15 Driver and Hole Punch by Xenco Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Xenco Medical Llc
Sources (1)
- FDA UDI a363ea64-21a4-4cce-a98b-7d20a139e165 32 fields · synced May 31, 2026