Identity
- Trade Name
- MCI - Medical Concept Innovation, Inc. FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- AUTO DRIVE SCREW N 1.5 X 3MM FDA UDI
- Model / Reference
- A01.02.0000 FDA UDI
- Description
- AUTO DRIVE SCREW N 1.5 X 3MM FDA UDI
Identifiers
- Catalog Number
- A01.02.0000 FDA UDI
- Primary DI / UDI-DI
- 00811687031801 FDA UDI
- 510(k) Number
- K212391 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable 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
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
Category: Craniofacial bone screw, non-bioabsorbable
MCI - Medical Concept Innovation, Inc. by Mci Medical Concept Innovation Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- MatrixMANDIBLE — Synthes · Class II
- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
Cleared under the same submission
K212391 also covers:
- MCI - MEDICAL CONCEPT INNOVATION, INC — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC.
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION 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
- Mci Medical Concept Innovation Inc.
Sources (1)
- FDA UDI e4eeb7e0-3fbc-45a1-bc6e-4213e8bd6917 36 fields · synced May 30, 2026