Identity
- Trade Name
- Uniglide Unicondylar Knee Prosthesis FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Device Name
- UNIGLIDE FIXED TIBIA FDA UDI
- Model / Reference
- 530.1511 FDA UDI
- Description
- UNIGLIDE FIXED TIBIA FDA UDI
Identifiers
- Catalog Number
- 530.1511 FDA UDI
- Primary DI / UDI-DI
- 05055196907140 FDA UDI
- 510(k) Number
- K050764 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Unicondylar knee insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Unicondylar knee insert
Uniglide Unicondylar Knee Prosthesis by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee insert.
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- GMK Uni — Medacta International · Class II
- SIGMA — DEPUY (IRELAND) · Class II
Cleared under the same submission
K050764 also covers:
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD
- Uniglide Unicondylar Knee Prosthesis — 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 f1c14ab9-9bac-47b3-a119-f8735761dc7a 36 fields · synced May 30, 2026