Identity
- Trade Name
- CMF VISIONARE FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Emergency Self-Tapping Screw D2.7mm, 12mm FDA UDI
- Model / Reference
- 1.900.324 FDA UDI
- Description
- Emergency Self-Tapping Screw D2.7mm, 12mm FDA UDI
Identifiers
- Catalog Number
- 1.900.324 FDA UDI
- Primary DI / UDI-DI
- 10810004516172 FDA UDI
- 510(k) Number
- K180204 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Category: Craniofacial bone screw, non-bioabsorbable, non-sterile
Cmf Visionare by Visionare Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable, non-sterile.
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- OsteoMed — Osteomed Corp. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
Cleared under the same submission
K180204 also covers:
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
- CMF VISIONARE — VISIONARE LLC
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
- Visionare Llc
Sources (1)
- FDA UDI 8f9d6ea3-a992-4370-86d0-1c1b8c0ac02e 36 fields · synced Jun 8, 2026