510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951626Substantially Equivalent for Some Indications

Synthes (u.s.a.) Universal Spinal Hook, Rod and Pedicle/sacral Screw Fixation System

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

K951626 is the FDA 510(k) clearance record for SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM, 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 K951626.

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