Identity
- Trade Name
- NovoKnee Total Knee System FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- HC PS Tibial Insert Size 5 13mm Trial FDA UDI
- Model / Reference
- 3311-3035 FDA UDI
- Description
- HC PS Tibial Insert Size 5 13mm Trial FDA UDI
Identifiers
- Catalog Number
- 3311-3035 FDA UDI
- Primary DI / UDI-DI
- 00811382036385 FDA UDI
- 510(k) Number
- K123339 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, 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
Dimensions & Sizes
- Size
- Height — 13 Millimeter FDA UDI
Category: Knee tibia prosthesis trial, 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 Knee tibia prosthesis trial, reusable.
- JOURNEY — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
- ACS® — implantcast GmbH · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novosource, Inc.
Sources (1)
- FDA UDI eeba8f8a-6035-463b-ac88-33ea9f47ed38 37 fields · synced Jun 8, 2026