510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011386Substantially Equivalent

Ebi Osteostim Granules-Resorbable Bone Graft Substitute

Ebi, LLC, Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011386 is the FDA 510(k) clearance record for EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE, a class II device, cleared for Ebi, L.P. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 99 510(k) clearances for Ebi, L.P., from to . As of , FDA records show no recalls naming K011386.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Ebi, L.P. 399 Jefferson Rd., Parsippany NJ
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 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