Identity
- Trade Name
- SMARTLOCK FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- LOCKING SCREW, SELF DRILLING FDA UDI
- Model / Reference
- 50-20598E FDA UDI
- Description
- LOCKING SCREW, SELF DRILLING FDA UDI
Identifiers
- Catalog Number
- 50-20598E FDA UDI
- Primary DI / UDI-DI
- 04546540732064 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 8.0 Millimeter FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
Smartlock by Stryker Leibinger — 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
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · 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
Cleared under the same submission
K122313 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Leibinger
Sources (1)
- FDA UDI c2cb3cef-7ece-4243-a5e7-de460ea6242e 36 fields · synced May 30, 2026