510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953653Substantially Equivalent

Lubinus Sp II Hip System

Turnkey Intergration USA, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953653 is the FDA 510(k) clearance record for LUBINUS SP II HIP SYSTEM, a class II device, cleared for Turnkey Intergration USA, Inc. on under FDA product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal). FDA records list 26 510(k) clearances for Turnkey Intergration USA, Inc., from to . As of , FDA records show 5 recalls naming K953653.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Turnkey Intergration USA, Inc. 6060 Castleway Dr. W., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code JDG

Trailing 12 months

FDA records hold no clearances under product code JDG in the trailing twelve months.

FDA records show no clearances under product code JDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDG, 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