Identity
- Trade Name
- Unity Total Knee System FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Device Name
- Patella Compression Attachment FDA UDI
- Model / Reference
- 123.083.30 FDA UDI
- Description
- Patella Compression Attachment FDA UDI
Identifiers
- Catalog Number
- 123.083.30 FDA UDI
- Primary DI / UDI-DI
- 05055343890752 FDA UDI
- 510(k) Number
- K113060 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, 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: Orthopaedic implant aiming/guiding block, reusable
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 implant aiming/guiding block, reusable.
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- MAXIM STEMMED TIBIAL MASK — Biomet Orthopedics, Inc. · Class I
- VISIONAIRE — Smith & Nephew, Inc. · Class II
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Oxford Uni Knee System — Biomet Uk Ltd · Class I
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Journey — Smith & Nephew, Inc. · Class I
- Femoral Cutting Block — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
Cleared under the same submission
K113060 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 |
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Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI a28f5af2-339b-49a5-a2d7-e47f3bfdbed9 36 fields · synced May 30, 2026