GMReis Ankle Plating System

FDA UDI

Class II (US FDA UDI)

by Gm Dos Reis Industria E Comercio Ltda

Identity

Trade Name: GMReis Ankle Plating System FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: VERSALOCK TORXDRIVE LOCKING SCREW LOW PROFILE Ø3.5/2.7MM X28MM T10 FDA UDI
Model / Reference: VERSALOCK TORXDRIVE LOCKING SCREW LOW PROFILE Ø3.5/2.7MM X28MM T10 FDA UDI
Description: VERSALOCK TORXDRIVE LOCKING SCREW LOW PROFILE Ø3.5/2.7MM X28MM T10 FDA UDI

Identifiers

Catalog Number: 223-3527-28-B FDA UDI
Primary DI / UDI-DI: 07899258627816 FDA UDI
510(k) Number: K242998 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

GMReis Ankle Plating System by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

Cleared under the same submission

K242998 also covers:

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: Gm Dos Reis Industria E Comercio Ltda

Sources (1)

FDA UDI a6335a6c-a0e0-42f2-94a5-4e3810f6c706 35 fields · synced Jun 7, 2026