510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040765Substantially Equivalent

Synthes 5.0/7.3 Mm Cannulated Locking Screws

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040765 is the FDA 510(k) clearance record for SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS, a class II device, cleared for Synthes (Usa) on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K040765.

Clearance record

Decision date
Received
(18 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDW

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