510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013790Substantially Equivalent

Calcigen-S Bone Void Filer

Biomet Orthopedics, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013790 is the FDA 510(k) clearance record for CALCIGEN-S BONE VOID FILER, a class II device, cleared for Biomet Orthopedics, Inc. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 40 510(k) clearances for Biomet Orthopedics, Inc., from to . As of , FDA records show no recalls naming K013790.

Clearance record

Decision date
Received
(209 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 Orthopedics, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code MQV

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