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Redapt

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
REDAPT FDA UDI
Generic Name
Press-fit femoral stem prosthesis FDA UDI
Device Name
REDAPT MODULAR SLEEVED STEM 240MM SZ 15 FDA UDI
Model / Reference
71354360 FDA UDI
Description
REDAPT MODULAR SLEEVED STEM 240MM SZ 15 FDA UDI

Identifiers

Catalog Number
71354360 FDA UDI
Primary DI / UDI-DI
00885556212844 FDA UDI
510(k) Number
K121627 FDA UDI
FDA Product Code
LZO FDA UDI
GMDN Term
Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
Commercial Distribution
Not 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

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

Cleared under the same submission

K121627 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 31e65edd-9742-4b4a-ac66-867d9b383d8f 37 fields · synced Jun 8, 2026