Identity
- Trade Name
- Bioplate® FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- Flexible Burr Hole Cover - Ø1.9 mm - 6 hole - 12 mm FDA UDI
- Model / Reference
- 81-2046[US] FDA UDI
- Description
- Flexible Burr Hole Cover - Ø1.9 mm - 6 hole - 12 mm FDA UDI
Identifiers
- Catalog Number
- 81-2046[US] FDA UDI
- Primary DI / UDI-DI
- M384812046US0 FDA UDI
- FDA Product Code
- GXR FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Bioplate is a flexible, non-bioabsorbable craniofacial fixation plate designed to bridge and stabilize fractures or craniotomy flaps. Made of durable materials such as surgical steel or titanium alloy, it features a variety of designs, including Y-plates, curved plates, mesh panels, and burr hole covers. The Bioplate is intended for single-use implantation and has been cleared by the FDA as a medical device. It can be used in conjunction with other devices to facilitate plate fixation and provide support during recovery.
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 07f5a947-095a-40a0-a9d7-543ad95d0c23 36 fields · synced Jul 22, 2026