TaperFit Cemented Hip System

FDA UDI

Class II (US FDA UDI)

by Corin Ltd

Identity

Trade Name: TaperFit Cemented Hip System FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: 45mm OFFSET RASP SIZE 3 FDA UDI
Model / Reference: 588.9453 FDA UDI
Description: 45mm OFFSET RASP SIZE 3 FDA UDI

Identifiers

Catalog Number: 588.9453 FDA UDI
Primary DI / UDI-DI: 05055343868829 FDA UDI
510(k) Number: K142761 FDA UDI
FDA Product Code: JDG FDA UDI
JDI FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3360 FDA UDI
888.3350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, manual, reusable

TaperFit Cemented Hip System by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 e52246f3-f9a6-425a-91df-85f7dd286c25 36 fields · synced May 31, 2026