510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904746Substantially Equivalent

S-Rom(tm) Femoral Stem Centralizer/cement Spacer

Joint Medical Products Corp., Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904746 is the FDA 510(k) clearance record for S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER, a class II device, cleared for Joint Medical Products Corp. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 33 510(k) clearances for Joint Medical Products Corp., from to . As of , FDA records show no recalls naming K904746.

Clearance record

Decision date
Received
(33 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
Joint Medical Products Corp. 860 Canal St., Stamford CT
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