Identity
- Trade Name
- UNIVERSAL NEURO 2, UNIVERSAL NEURO III FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS FDA UDI
- Model / Reference
- 54-00345 FDA UDI
- Description
- DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS FDA UDI
Identifiers
- Catalog Number
- 54-00345 FDA UDI
- Primary DI / UDI-DI
- 04546540684868 FDA UDI
- 510(k) Number
- K983528 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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 — 120.0 Millimeter FDA UDIWidth — 120.0 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Universal Neuro 2, Universal Neuro Iii by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
Cleared under the same submission
K983528 also covers:
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
- Stryker Leibinger
Sources (1)
- FDA UDI 171cf3c6-08dd-4d42-a4cb-9fe97e40c2f9 36 fields · synced May 30, 2026