Identity
- Trade Name
- UNIVERSAL NEURO 3 FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- Gap Plate, large FDA UDI
- Model / Reference
- 53-34622 FDA UDI
- Description
- Gap Plate, large FDA UDI
Identifiers
- Catalog Number
- 53-34622 FDA UDI
- Primary DI / UDI-DI
- 04546540684820 FDA UDI
- 510(k) Number
- K112557 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
MR Conditional FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Universal Neuro 3 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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- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
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Cleared under the same submission
K112557 also covers:
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
- UNIVERSAL NEURO 3 — Stryker Leibinger
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 f8969a02-2b79-42a6-8c54-78a49b7859cc 36 fields · synced May 30, 2026