Identity
- Trade Name
- Stratum Ankle FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Stratum Ankle Locking Screw Sterile 5.0mmX60mm FDA UDI
- Model / Reference
- SALS5060S FDA UDI
- Description
- Stratum Ankle Locking Screw Sterile 5.0mmX60mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810082890877 FDA UDI
- 510(k) Number
- K212640 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
A comprehensive lockable ankle device used for internal orthopaedic fixation, suitable for use on the femur, tibia, fibula, humerus, scapula, and sternum. It is designed to provide direct interfragmentary stabilization of a fractured bone.
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K212640 also covers:
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
- Stratum Ankle — Medartis Inc.
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
- Medartis Inc.
Sources (1)
- FDA UDI 5cf6287a-ce06-4fc6-9998-8dfddfb31bf3 34 fields · synced Jul 24, 2026