Identity
- Trade Name
- Neuro & Craniofacial Fixation System FDA UDI
- Generic Name
- Cranioplasty plate screw FDA UDI
- Device Name
- Ti 6Al 4V (ELI) FDA UDI
- Model / Reference
- CRT1604 FDA UDI
- Description
- Ti 6Al 4V (ELI) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M711CRT16040 FDA UDI
- 510(k) Number
- K141452 FDA UDI
- FDA Product Code
- HBW FDA UDI
- GMDN Term
- Cranioplasty plate screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5360 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 4 Millimeter FDA UDIOuter Diameter — 1.6 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customizedCranioplasty plate screw
Neuro & Craniofacial Fixation System by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141452 also covers:
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
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
- Innovasis, Inc.
Sources (1)
- FDA UDI 64c9ae49-6104-4590-bbde-d5c5573abe58 36 fields · synced May 29, 2026