Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Cranioplasty plate, alterable FDA UDI
- Device Name
- SmartFlex Spring - Small - 8.5N FDA UDI
- Model / Reference
- 218-3085-SP FDA UDI
- Description
- SmartFlex Spring - Small - 8.5N FDA UDI
Identifiers
- Catalog Number
- 218-3085-SP FDA UDI
- Primary DI / UDI-DI
- 00845694045049 FDA UDI
- FDA Product Code
- PBJ FDA UDI
- GMDN Term
- Cranioplasty plate, alterable 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranioplasty plate, alterable
OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranioplasty plate, alterable.
- Innovasis® Cranial System — Innovasis, Inc. · Class II
- Innovasis® Cranial System — Innovasis, Inc. · Class II
- Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class II
- "1.5MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC · Class II
- Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class II
- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
- Neuro & Craniofacial Fixation System — Innovasis, Inc. · Class II
- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
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
- Osteomed Corp.
Sources (1)
- FDA UDI 05bb063a-c728-444e-9521-671887ae5b25 36 fields · synced May 30, 2026