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Total Foot System 2

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Total Foot System 2 FDA UDI
Generic Name
Bone approximation clamp FDA UDI
Device Name
SERRATED BONE CLAMP FDA UDI
Model / Reference
321012 FDA UDI
Description
SERRATED BONE CLAMP FDA UDI

Identifiers

Catalog Number
321012 FDA UDI
Primary DI / UDI-DI
00885556822944 FDA UDI
FDA Product Code
HXD FDA UDI
GMDN Term
Bone approximation clamp FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone approximation clamp

Total Foot System 2 by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone approximation clamp.

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 03dce303-a05a-4393-b5db-c7b862d65ce1 36 fields · synced Jun 8, 2026