510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K902397Substantially Equivalent for Some Indications

Modulock Posterior Spinal Fixation

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K902397 is the FDA 510(k) clearance record for MODULOCK POSTERIOR SPINAL FIXATION, a class II device, cleared for Zimmer, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K902397.

Clearance record

Decision date
Received
(159 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260