Identity
- Trade Name
- K2M General Instruments FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Parallel Modular Trial, Size 22x60x10 mm, 0° FDA UDI
- Model / Reference
- AG01-96060 FDA UDI
- Description
- Parallel Modular Trial, Size 22x60x10 mm, 0° FDA UDI
Identifiers
- Catalog Number
- AG01-96060 FDA UDI
- Primary DI / UDI-DI
- 10888857429765 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDIWidth — 22 Millimeter FDA UDILength — 60 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
K2M General Instruments by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- K2m, Inc.
Sources (1)
- FDA UDI eb9aff72-910b-4cf0-a7b6-52a7eec4220d 36 fields · synced May 29, 2026