510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970084Substantially Equivalent

Link Cerclage Wire System

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

K970084 is the FDA 510(k) clearance record for LINK CERCLAGE WIRE SYSTEM, a class II device, cleared for Turnkey Intergration USA, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 26 510(k) clearances for Turnkey Intergration USA, Inc., from to . As of , FDA records show no recalls naming K970084.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Turnkey Intergration USA, Inc. 962 S. Tamiami Trl. Suite 203, Sarasota FL
510(k) summary
Statement
Third party review
No

Clearances, product code JDQ

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