510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010528Unknown

Titanium Cement Restrictor Material Peek

Medtronic Sofamor Danek USA Inc, Memphis TN / Traditional, Unknown
FDA source (opens on fda.gov)

K010528 is the FDA 510(k) clearance record for TITANIUM CEMENT RESTRICTOR MATERIAL PEEK, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K010528.

Clearance record

Decision date
Received
(229 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
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary
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