Cleared Traditional

K963587 - WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) (FDA 510(k) Clearance)

K963587 · Wrightmedicaltechnologyinc · Orthopedic device

Mar 1997

Decision

196d

Days

Class 2

Risk

K963587 is an FDA 510(k) clearance for the WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION). This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 24, 1997, 196 days after receiving the submission on September 9, 1996.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K963587 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 09, 1996
Decision Date	March 24, 1997
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF