Identity
- Trade Name
- TORNIER PERFORM™ HUMERAL SYSTEM FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- MWX3PS FDA UDI
Identifiers
- Catalog Number
- MWX3PS FDA UDI
- Primary DI / UDI-DI
- 00846832082568 FDA UDI
- FDA Product Code
- KWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
The TORNIER PERFORM HUMERAL SYSTEM is a hand-held surgical instrument designed to aid in the positioning and implantation of orthopaedic prostheses. With its reusable design, this device simplifies the process for surgeons and patients alike, offering precise placement and alignment of components.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 37d261ab-824e-43a1-8b21-f2d5c6ab32d1 35 fields · synced Aug 3, 2026