← Back to catalogue

Quick - Radius Disposable Set

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K231684

by Gm Dos Reis Industria E Comercio Ltda

Identity

Trade Name
Quick - Radius Disposable Set FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
Versalock Screw Ti T7 FDA UDI
Model / Reference
Versalock Screw Ti T7 FDA UDI
Description
Versalock Screw Ti T7 FDA UDI

Identifiers

Catalog Number
223-24-18-BPS FDA UDI
Primary DI / UDI-DI
07899258659640 FDA UDI
510(k) Number
K231684 FDA 510(k)FDA UDI
FDA Product Code
HRS FDA 510(k)FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)FDA UDI
888.3040 FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Quick - Radius Disposable Set by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Gm Dos Reis Industria E Comercio Ltda
FDA Applicant
GM Dos Reis Industria e Comercio Ltda.

Sources (2)

  • FDA 510(k) K231684 24 fields · synced Jun 19, 2026
  • FDA UDI d38bf0dd-67e8-4ccc-bf22-990d252f459c 35 fields · synced May 26, 2026