Identity
- Trade Name
- NovoKnee Total Knee System FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- Femoral A\P Chamfer Cutting Guide Sz 1 FDA UDI
- Model / Reference
- 3120-5010 FDA UDI
- Description
- Femoral A\P Chamfer Cutting Guide Sz 1 FDA UDI
Identifiers
- Catalog Number
- 3120-5010 FDA UDI
- Primary DI / UDI-DI
- 00811382035050 FDA UDI
- 510(k) Number
- K123339 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
NovoKnee Total Knee System by Novosource, Inc. — 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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- PROPHECY — MicroPort Orthopedics Inc. · Class II
- 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
K123339 also covers:
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, Inc.
- NovoKnee Total Knee System — Novosource, 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
- Novosource, Inc.
Sources (1)
- FDA UDI 5b540352-79eb-4d8e-99ae-8abd53ba2fe5 37 fields · synced Jun 7, 2026