510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062986Substantially Equivalent

Medtronic Graft Delivery Syringe

Medtronic Sofamor Danek USA Inc, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062986 is the FDA 510(k) clearance record for MEDTRONIC GRAFT DELIVERY SYRINGE, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code FMF (Syringe, Piston). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K062986.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

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