Cleared Traditional

K960978 - WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) (FDA 510(k) Clearance)

K960978 · Wrightmedicaltechnologyinc · Orthopedic device

Jun 1996

Decision

102d

Days

Class 2

Risk

K960978 is an FDA 510(k) clearance for the WRIGHT PLASTER OF PARIS PELLETS (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 June 21, 1996, 102 days after receiving the submission on March 11, 1996.

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

Submission Details

510(k) Number	K960978 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 1996
Decision Date	June 21, 1996
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF