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Integra® Total Foot System"

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Integra® Total Foot System" FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The fore foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. FDA UDI
Model / Reference
TFSFOREFTIMP FDA UDI
Description
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The fore foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. FDA UDI

Identifiers

Catalog Number
TFSFOREFTIMP FDA UDI
Primary DI / UDI-DI
10381780064589 FDA UDI
510(k) Number
K100502 FDA UDI
K123000 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Integra® Total Foot System" by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K100502 also covers:

K123000 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 935e1db1-a50b-4067-b945-7ef1145ddb4b 37 fields · synced Jun 1, 2026