Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- Profile Zero Y Plate FDA UDI
- Model / Reference
- 218-0205 FDA UDI
- Description
- Profile Zero Y Plate FDA UDI
Identifiers
- Catalog Number
- 218-0205 FDA UDI
- Primary DI / UDI-DI
- 00845694034111 FDA UDI
- FDA Product Code
- GWO FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5320 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 19 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
OsteoMed by Osteomed Corp. — 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
- CMF VISIONARE — VISIONARE LLC · Class II
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
- AccuPlate® Patient-Specific Plate — Medcad · 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 e1346674-22e1-4809-bf83-8b2336e73cb6 36 fields · synced Jun 8, 2026