Identity
- Trade Name
- TaperFit Cemented Hip System FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- TaperFit Hip Stem 38mm Offset Narrow Stem size 2 FDA UDI
- Model / Reference
- 588.3802 FDA UDI
- Description
- TaperFit Hip Stem 38mm Offset Narrow Stem size 2 FDA UDI
Identifiers
- Catalog Number
- 588.3802 FDA UDI
- Primary DI / UDI-DI
- 05055343868485 FDA UDI
- 510(k) Number
- K142761 FDA UDI
- FDA Product Code
- JDI FDA UDIJDG FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3360 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: Uncoated hip femur prosthesis, modular
TaperFit Cemented Hip System by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
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- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
Cleared under the same submission
K142761 also covers:
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip 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 0eecaadc-81f1-47e8-b4da-d9c9e8e3893b 36 fields · synced May 30, 2026