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Integra®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
FGT System Cutting Guide, Large Instrument utilized to resect the base of the proximal phalanx and distal portion of the metatarsal head. FDA UDI
Model / Reference
FGT-CG2LT FDA UDI
Description
FGT System Cutting Guide, Large Instrument utilized to resect the base of the proximal phalanx and distal portion of the metatarsal head. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780257394 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide 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: Custom-made orthopaedic/craniofacial surgical guide

Integra® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

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 9bcd839b-5cab-4f1b-839d-4a13c5b79abf 35 fields · synced Jun 1, 2026