Identity
- Trade Name
- Modal Total Knee System FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- Patellar Drill & Cement Clamp FDA UDI
- Model / Reference
- M-3420-5001 FDA UDI
- Description
- Patellar Drill & Cement Clamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- B035M342050011 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Joint prosthesis implantation kit, reusable
Modal Total Knee System by Modal Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, reusable.
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- Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
- Evolution — MicroPort Orthopedics Inc. · Class II
- GUARDIAN® — MicroPort Orthopedics Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K142649 also covers:
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
K150783 also covers:
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
- STERIZO Total Knee System — CPM Medical Consultants, LLC
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
- Modal Manufacturing Llc
Sources (1)
- FDA UDI 2ba5a9b5-d965-4a8a-9728-cff06a6f71e0 34 fields · synced Jun 1, 2026