510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033953Unknown

Optimesh 500E Cement Restrictor

Spineology, Inc., Stillwater MN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033953 is the FDA 510(k) clearance record for OPTIMESH 500E CEMENT RESTRICTOR, a class II device, cleared for Spineology, Inc. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 54 510(k) clearances for Spineology, Inc., from to . As of , FDA records show no recalls naming K033953.

Clearance record

Decision date
Received
(197 days to decision)
Product code
JDK Prosthesis, Hip, Cement Restrictor
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Spineology, Inc. 1815 Northwestern Ave., Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDK

Trailing 12 months

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

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