Identity
- Trade Name
- Tornier Flex FDA UDI
- Generic Name
- Orthopaedic fixation plate tensioner FDA UDI
- Device Name
- Long Stem+ Compactor FDA UDI
- Model / Reference
- MWF612S FDA UDI
- Description
- Long Stem+ Compactor FDA UDI
Identifiers
- Catalog Number
- MWF612S FDA UDI
- Primary DI / UDI-DI
- 03700386977282 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Orthopaedic fixation plate tensioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Orthopaedic fixation plate tensioner
Tornier Flex by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate tensioner.
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- SMALL FRAG TENSIONER — Biomet Orthopedics, Inc. · Class I
- Apelo® / Apelo® MIS — ATLAS SPINE INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI d06535e7-7b5a-4b7c-91e5-f568f6db74a5 36 fields · synced May 31, 2026