Identity
- Trade Name
- Bioplate® FDA UDI
- Generic Name
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK] FDA UDI
- Model / Reference
- 81-3578[US] FDA UDI
- Description
- X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK] FDA UDI
Identifiers
- Catalog Number
- 81-3578[US] FDA UDI
- Primary DI / UDI-DI
- M384813578US0 FDA UDI
- 510(k) Number
- K082757 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Neurosurgical procedure kit, non-medicated, single-use 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
MR Conditional FDA UDI
Category: Neurosurgical procedure kit, non-medicated, single-use
Bioplate® by Bioplate, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurosurgical procedure kit, non-medicated, single-use.
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Cleared under the same submission
K082757 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA UDI 64731215-4090-4ad0-9da1-59b744755389 36 fields · synced May 30, 2026