Identity
- Trade Name
- Bioplate® FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- Mesh Plate - Ø1.9 mm FDA UDI
- Model / Reference
- 81-5791-CP FDA UDI
- Description
- Mesh Plate - Ø1.9 mm FDA UDI
Identifiers
- Catalog Number
- 81-5791-CP FDA UDI
- Primary DI / UDI-DI
- M384815791CP0 FDA UDI
- 510(k) Number
- K062819 FDA UDI
- FDA Product Code
- GXN FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Bioplate® by Bioplate, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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Cleared under the same submission
K062819 also covers:
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
- Bioplate, Inc.
Sources (1)
- FDA UDI 22be1c6e-a5b0-404f-a475-884f29d0c17a 37 fields · synced Jun 6, 2026