510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864375Substantially Equivalent for Some Indications

Type 316L Cotter Wire

Winn Hirsch & Assoc., Plainview NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K864375 is the FDA 510(k) clearance record for TYPE 316L COTTER WIRE, a class II device, cleared for Winn Hirsch & Assoc. on under FDA product code LRN (Wire, Surgical). FDA records list 11 510(k) clearances for Winn Hirsch & Assoc., from to . As of , FDA records show no recalls naming K864375.

Clearance record

Decision date
Received
(196 days to decision)
Product code
LRN Wire, Surgical
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Winn Hirsch & Assoc. 30 Sylvia Rd., Plainview NY
Third party review
No

Clearances, product code LRN

Trailing 12 months

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

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