510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K093670Substantially Equivalent

Modification to: Oasys System

Howmedica Osteonics Corp, Allendale NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093670 is the FDA 510(k) clearance record for MODIFICATION TO: OASYS SYSTEM, a class II device, cleared for Stryker Spine on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list 377 510(k) clearances for HOWMEDICA OSTEONICS CORP, from to . As of , FDA records show one recall naming K093670.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Spine 2 Pearl Ct., Allendale NJ
510(k) summary
Summary PDF
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