Cleared Traditional

K010532 - OSTEOSET BVF KIT (FDA 510(k) Clearance)

K010532 · Wrightmedicaltechnologyinc · Orthopedic device

Oct 2001

Decision

245d

Days

Class 2

Risk

K010532 is an FDA 510(k) clearance for the OSTEOSET BVF KIT. 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 October 26, 2001, 245 days after receiving the submission on February 23, 2001.

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

Submission Details

510(k) Number	K010532 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 2001
Decision Date	October 26, 2001
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF