Redapt

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: REDAPT FDA UDI
Generic Name: Uncoated hip femur prosthesis, modular FDA UDI
Device Name: REDAPT MODULAR SLEEVE 11 XS GRIT-BLASTED FDA UDI
Model / Reference: 71354211 FDA UDI
Description: REDAPT MODULAR SLEEVE 11 XS GRIT-BLASTED FDA UDI

Identifiers

Catalog Number: 71354211 FDA UDI
Primary DI / UDI-DI: 00885556254226 FDA UDI
510(k) Number: K100481 FDA UDI
FDA Product Code: MEH FDA UDI
GMDN Term: Uncoated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Uncoated hip femur prosthesis, modular

Redapt by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Uncoated hip femur prosthesis, modular.

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S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
Corin Taper-Fit Total Hip System — CORIN LTD · Class II
TaperFit Cemented Hip System — CORIN LTD · Class II
Omnifit — Howmedica Osteonics Corp. · Class II
SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

K100481 also covers:

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: Smith & Nephew, Inc.

Sources (1)

FDA UDI 0d5b66a5-84fe-49f4-9ca6-c1d6a0f4258f 36 fields · synced Jun 8, 2026