Versalock Periprosthetic Femur Plates System-GMReis

FDA UDI

Class II (US FDA UDI)

by Gm Dos Reis Industria E Comercio Ltda

Identity

Trade Name: Versalock Periprosthetic Femur Plates System-GMReis FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: MIS VERSALOCK CONDYLAR FEMUR PLATE 13H - LEFT FDA UDI
Model / Reference: Condilar Plate FDA UDI
Description: MIS VERSALOCK CONDYLAR FEMUR PLATE 13H - LEFT FDA UDI

Identifiers

Catalog Number: 327-13-E FDA UDI
Primary DI / UDI-DI: 07899258657844 FDA UDI
510(k) Number: K201728 FDA UDI
FDA Product Code: HRS FDA UDI
JDP FDA UDI
HWC FDA UDI
JDQ FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
888.3010 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Versalock Periprosthetic Femur Plates System-GMReis by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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Cleared under the same submission

K201728 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

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Manufacturer

Manufacturer: Gm Dos Reis Industria E Comercio Ltda

Sources (1)

FDA UDI d7353379-7547-4156-b456-70b35343a880 35 fields · synced May 30, 2026