510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963357Substantially Equivalent for Some Indications

Modification to the Synthes (USA) Universal Spinal Hook, Rod, and and Sacral Screw Fixation System in 316L Stainless Ste

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K963357 is the FDA 510(k) clearance record for MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE, a class II device, cleared for Synthes (Usa) on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K963357.

Clearance record

Decision date
Received
(136 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
Third party review
No

Clearances, product code MNH

Trailing 12 months

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

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