510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041089Substantially Equivalent

Oss Bone Graft System and Oss Rapidset Bone Graft System

Biomet Manufacturing Corp, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041089 is the FDA 510(k) clearance record for OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM, a class II device, cleared for Biomet Manufacturing, Inc. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 128 510(k) clearances for Biomet Manufacturing, Inc., from to . As of , FDA records show no recalls naming K041089.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing, Inc. 56 E Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQV

Trailing 12 months
5 clearances under product code MQV in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQV, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260