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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
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- ACETABULAR REAMER 40MM FDA UDI
- Model / Reference
- S299.740 FDA UDI
- Description
- ACETABULAR REAMER 40MM FDA UDI
Identifiers
- Catalog Number
- S299.740 FDA UDI
- Primary DI / UDI-DI
- 05055343887424 FDA UDI
- 510(k) Number
- K994153 FDA UDI
- FDA Product Code
- KXA FDA UDI
- GMDN Term
- Acetabular orthopaedic reamer 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: Acetabular orthopaedic reamer
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 Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
- Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
- U2 Total Knee System — United Orthopedic Corporation · Class IIa
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 |
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Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI f52a0669-bb7b-4041-b0fc-ceb60f873078 36 fields · synced May 30, 2026