510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080367Substantially Equivalent

Zimmer Mis Light

Zimmer Spine, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080367 is the FDA 510(k) clearance record for ZIMMER MIS LIGHT, a class II device, cleared for Zimmer Spine, Inc. on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list 50 510(k) clearances for Zimmer Spine, Inc., from to . As of , FDA records show no recalls naming K080367.

Clearance record

Decision date
Received
(10 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Zimmer Spine, Inc. 7375 Bush Lake Rd., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FST

Trailing 12 months

FDA records hold no clearances under product code FST in the trailing twelve months.

FDA records show no clearances under product code FST in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FST, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260