510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030871Unknown

Fidji Large Cement Restrictor

Spine Next SA, Queenstown MD / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030871 is the FDA 510(k) clearance record for FIDJI LARGE CEMENT RESTRICTOR, a class II device, cleared for Spine Next SA on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 3 510(k) clearances for Spine Next SA, from to . As of , FDA records show no recalls naming K030871.

Clearance record

Decision date
Received
(278 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
Spine Next SA 104 Greenwood Creek Rd., Queenstown MD
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