Identity
- Trade Name
- Flex Shoulder System FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- HANDLE FDA UDI
- Model / Reference
- MWF724Z1 FDA UDI
- Description
- HANDLE FDA UDI
Identifiers
- Catalog Number
- MWF724Z1 FDA UDI
- Primary DI / UDI-DI
- 03700386987991 FDA UDI
- 510(k) Number
- DEN220012 FDA UDI
- FDA Product Code
- QKW FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3695 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
Flex Shoulder System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
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- R3 — Smith & Nephew, Inc. · Class I
Cleared under the same submission
DEN220012 also covers:
- Aequalis Pyrocarbon Humeral Head — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Tornier Flex Shoulder System — TORNIER, 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
- Tornier, Inc.
Sources (1)
- FDA UDI d161e6ea-2336-44f5-9a11-4b8c883e3126 36 fields · synced Jun 8, 2026