Identity
- Trade Name
- Bioplate® FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- T Plate - Ø1.5 mm - 5 hole - 15 mm FDA UDI
- Model / Reference
- 81-2004[US] FDA UDI
- Description
- T Plate - Ø1.5 mm - 5 hole - 15 mm FDA UDI
Identifiers
- Catalog Number
- 81-2004[US] FDA UDI
- Primary DI / UDI-DI
- M384812004US0 FDA UDI
- 510(k) Number
- K002426 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 15 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
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
Cleared under the same submission
K002426 also covers:
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
- Bioplate® — Bioplate, Inc.
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 7baec82f-6e85-42ea-a67c-c5ac7b0657c2 37 fields · synced Jun 1, 2026