510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953635Substantially Equivalent for Some Indications

Titanium Dyna-Lok Spinal System

Sofamor Danek USA,Inc., Winona Lake IN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953635 is the FDA 510(k) clearance record for TITANIUM DYNA-LOK SPINAL SYSTEM, a class II device, cleared for Sofamor Danek USA,Inc. on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list 42 510(k) clearances for Sofamor Danek USA,Inc., from to . As of , FDA records show no recalls naming K953635.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Sofamor Danek USA,Inc. 100 Publishers Dr., Winona Lake IN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNH, 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