510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010529Unknown

Titanium Cement Restrictor Material Pldla

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

K010529 is the FDA 510(k) clearance record for TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K010529.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code JDI

Trailing 12 months
3 clearances under product code JDI in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260