← Back to catalogue
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
FDA UDIClass II (US FDA UDI)
by Corin Ltd
Identity
- Trade Name
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- SI HEAD ALIGNMENT TEMPLATE SIZE 10 / 56MM FDA UDI
- Model / Reference
- 379.270 FDA UDI
- Description
- SI HEAD ALIGNMENT TEMPLATE SIZE 10 / 56MM FDA UDI
Identifiers
- Catalog Number
- 379.270 FDA UDI
- Primary DI / UDI-DI
- 05055196902985 FDA UDI
- 510(k) Number
- K994153 FDA UDI
- FDA Product Code
- KXA FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3400 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: Surgical implant template, reusable
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K994153 also covers:
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD
- Cormet 2000 Hemi-Hip Metallic Resurfacing 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI 86e7b007-53c2-44da-85c9-9d7bdaace5bf 36 fields · synced May 30, 2026