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APOLLO Ankle Fracture Plating System

FDA UDI

Class I (US FDA UDI)

by Glw, Inc.

Identity

Trade Name
APOLLO Ankle Fracture Plating System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Apollo Ankle Fracture Plates / Apollo K-wire Kit Ø1.6 / Single Use Kit FDA UDI
Model / Reference
F4-3009-000S FDA UDI
Description
Apollo Ankle Fracture Plates / Apollo K-wire Kit Ø1.6 / Single Use Kit FDA UDI

Identifiers

Catalog Number
F4-3009-000S FDA UDI
Primary DI / UDI-DI
18435711004907 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

APOLLO Ankle Fracture Plating System by Glw, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Glw, Inc.

Sources (1)

  • FDA UDI 81af68b8-c77b-40d9-9f31-d42397e6ee7d 34 fields · synced Jun 8, 2026