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Construct® Ankle Fusion Plate System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Construct® Ankle Fusion Plate System FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a major thread diameter of 4.5 or 6.5mm. All plates and screws are manufactured from stainless steel or titanium. The system is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions, and replantation of small bones in the foot and ankle. Instruments are provided. FDA UDI
Model / Reference
AFPIMP FDA UDI
Description
The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a major thread diameter of 4.5 or 6.5mm. All plates and screws are manufactured from stainless steel or titanium. The system is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions, and replantation of small bones in the foot and ankle. Instruments are provided. FDA UDI

Identifiers

Catalog Number
AFPIMP FDA UDI
Primary DI / UDI-DI
10381780064497 FDA UDI
510(k) Number
K100176 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

Construct® Ankle Fusion Plate System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 aba859c0-6180-415a-bdb8-3f124d549902 37 fields · synced Jun 1, 2026