Identity
- Trade Name
- SmartLock FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- SURGEON ID MAND RECON PLATE,L,FULL FDA UDI
- Model / Reference
- 92-41820E FDA UDI
- Description
- SURGEON ID MAND RECON PLATE,L,FULL FDA UDI
Identifiers
- Catalog Number
- 92-41820E FDA UDI
- Primary DI / UDI-DI
- 07613327459425 FDA UDI
- 510(k) Number
- K190696 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
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
SmartLock 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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Cleared under the same submission
K190696 also covers:
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — Stryker Leibinger
- SmartLock — 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 786ec664-8b45-4fc0-9841-b3951d725c02 36 fields · synced May 31, 2026