Cleared Traditional

K011531 - CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER (FDA 510(k) Clearance)

K011531 · Biomet, Inc. · Orthopedic device

Sep 2002

Decision

477d

Days

Class 2

Risk

K011531 is an FDA 510(k) clearance for the CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 6, 2002, 477 days after receiving the submission on May 17, 2001.

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

Submission Details

510(k) Number	K011531 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 17, 2001
Decision Date	September 06, 2002
Days to Decision	477 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF