510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041925Substantially Equivalent

St360 Spinal Fixation System

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

K041925 is the FDA 510(k) clearance record for ST360 SPINAL FIXATION SYSTEM, a class II device, cleared for Zimmer Spine, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 50 510(k) clearances for Zimmer Spine, Inc., from to . As of , FDA records show one recall naming K041925.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer Spine, Inc. 7375 Bush Lake Rd., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWP

Trailing 12 months

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

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, 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