510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140710Substantially Equivalent

Biomet Graft Delivery Syringes

Biomet Spine (Aka Ebi, LLC), Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140710 is the FDA 510(k) clearance record for BIOMET GRAFT DELIVERY SYRINGES, a class II device, cleared for Biomet Spine (Aka Ebi, LLC) on under FDA product code FMF (Syringe, Piston). FDA records list 13 510(k) clearances for Biomet Spine (Aka Ebi, LLC), from to . As of , FDA records show no recalls naming K140710.

Clearance record

Decision date
Received
(167 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Biomet Spine (Aka Ebi, LLC) 399 Jefferson Rd., Parsippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260