510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062495Substantially Equivalent

Healos Fx Bone Graft Substitute and Graft Mixing and Delivery System

DePuy Spine, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062495 is the FDA 510(k) clearance record for HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM, a class II device, cleared for Depuy Spine, Inc. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 71 510(k) clearances for Depuy Spine, Inc., from to . As of , FDA records show no recalls naming K062495.

Clearance record

Decision date
Received
(49 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy Spine, Inc. 325 Paramount Dr., Raynham MA
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