DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM— 510(k) K050932

Clearance details

Applicant

Hand Innovations, Inc.

Product code

Code LXT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2005-04-14

Decision date

2005-04-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Miami Lakes, FL, US

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• Z-1300-2022 — DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.Class II·Terminated·CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.·20220602

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050932.