510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945670Substantially Equivalent

Kirschner (K-Wire), Steinman Pins

Brasseler USA I, L.P., Savannah GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945670 is the FDA 510(k) clearance record for KIRSCHNER (K-WIRE), STEINMAN PINS, a class II device, cleared for Brasseler USA I, L.P. on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 4 510(k) clearances for Brasseler USA I, L.P., from to . As of , FDA records show 2 recalls naming K945670.

Clearance record

Decision date
Received
(109 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Brasseler USA I, L.P. 800 King George Blvd., Savannah GA
510(k) summary
Statement
Third party review
No

Clearances, product code JDW

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