Cleared Traditional

K963562 - WRIGHT PLASTER OF PARIS PELLETS (FDA 510(k) Clearance)

K963562 · Wrightmedicaltechnologyinc · Orthopedic device

May 1997

Decision

244d

Days

Class 2

Risk

K963562 is an FDA 510(k) clearance for the WRIGHT PLASTER OF PARIS PELLETS. 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 May 7, 1997, 244 days after receiving the submission on September 5, 1996.

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

Submission Details

510(k) Number	K963562 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 05, 1996
Decision Date	May 07, 1997
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF