Identity
- Trade Name
- 28mm x 11mm x 18mm Oblique with Inserter FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 28mm x 11mm x 18mm Oblique FDA UDI
- Model / Reference
- XM-011-2818 FDA UDI
- Description
- 28mm x 11mm x 18mm Oblique FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064XM01128181 FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- 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
28mm x 11mm x 18mm Oblique with Inserter by Xenco Medical Llc — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Xenco Medical Llc
Sources (1)
- FDA UDI 77bb0121-32b5-47d5-a38b-53293ddeedf5 33 fields · synced Jun 8, 2026