Identity
- Trade Name
- Unity Total Knee System FDA UDI
- Generic Name
- Orthopaedic knee-balance analyser, non-electrical FDA UDI
- Device Name
- Tensioner Paddle Flexion FDA UDI
- Model / Reference
- 123.116.24 FDA UDI
- Description
- Tensioner Paddle Flexion FDA UDI
Identifiers
- Catalog Number
- 123.116.24 FDA UDI
- Primary DI / UDI-DI
- 05055343891520 FDA UDI
- 510(k) Number
- K170808 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic knee-balance analyser, non-electrical 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: Orthopaedic knee-balance analyser, non-electrical
Unity Total Knee System by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic knee-balance analyser, non-electrical.
- Simple Gap Block, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Femoral Cut Block, Central Capture, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- GENESIS II — Smith & Nephew, Inc. · Class II
- Persona — Zimmer, Inc. · Class II
- Femoral Cut Block, Central Capture, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Simple Gap Block, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Simple Gap Block, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- GENESIS II — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K170808 also covers:
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
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
- Corin Ltd
Sources (1)
- FDA UDI 578ac8c0-ff99-4991-904e-c159c43db7e1 35 fields · synced May 30, 2026