Identity
- Trade Name
- ILIZAROV SYSTEMS FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- RATCHET WRENCH 10MM FDA UDI
- Model / Reference
- 71070367 FDA UDI
- Description
- RATCHET WRENCH 10MM FDA UDI
Identifiers
- Catalog Number
- 71070367 FDA UDI
- Primary DI / UDI-DI
- 00885556119174 FDA UDI
- 510(k) Number
- K093047 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Surgical torque wrench, reusable 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
No
FDA UDI
Implantable
No
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
Category: Surgical torque wrench, reusable
Ilizarov Systems by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093047 also covers:
- Anthology — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Ex-Fix — Smith & Nephew, Inc.
- Ex-Fix — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- MODULAR RAIL SYSTEM — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI d2429bc6-281a-4647-ad4e-2749348caa5a 36 fields · synced Jun 8, 2026