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: Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping. FDA UDI
Model / Reference: PSS4514CT FDA UDI
Description: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping. FDA UDI

Identifiers

Catalog Number: PSS4514CT FDA UDI
Primary DI / UDI-DI: 10381780117520 FDA UDI
510(k) Number: K100176 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic bone 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 7baaf5e1-bbf2-49ed-b50b-c153d9d8053a 38 fields · synced May 31, 2026