Integra Stainless Headed Compression Screw System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra Stainless Headed Compression Screw System FDA UDI
Generic Name: Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name: The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diamter 6.5mm or 7.5mm. FDA UDI
Model / Reference: HEADHNDSET FDA UDI
Description: The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diamter 6.5mm or 7.5mm. FDA UDI

Identifiers

Catalog Number: HEADHNDSET FDA UDI
Primary DI / UDI-DI: 10381780064619 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Integra Stainless Headed Compression Screw 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

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Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 9562543b-76b5-447e-b31c-21346620b7d6 37 fields · synced Jun 1, 2026