510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021719Unknown

Fortitude Cement Restrictor

Spinal Concepts, Inc., Austin TX / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021719 is the FDA 510(k) clearance record for FORTITUDE CEMENT RESTRICTOR, a class II device, cleared for Spinal Concepts, Inc. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 46 510(k) clearances for Spinal Concepts, Inc., from to . As of , FDA records show no recalls naming K021719.

Clearance record

Decision date
Received
(84 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
Spinal Concepts, Inc. 12012 Technology Blvd., #100, Austin TX
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDK, 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