Identity
- Trade Name
- SMART TSF FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- SMART TSF U RING 155MM INNER DIA FDA UDI
- Model / Reference
- 71075304 FDA UDI
- Description
- SMART TSF U RING 155MM INNER DIA FDA UDI
Identifiers
- Catalog Number
- 71075304 FDA UDI
- Primary DI / UDI-DI
- 00885556745502 FDA UDI
- 510(k) Number
- K210953 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: External orthopaedic fixation system, single-use
Smart Tsf by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- TRUELOK EVO — Orthofix, Inc. · Class II
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
Cleared under the same submission
K210953 also covers:
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, Inc.
- SMART TSF — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 5b21517c-b360-4050-8fc7-e879baf97020 36 fields · synced Jun 8, 2026