510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971962Substantially Equivalent

Osteo Kirschner Wires

Osteonics Corp., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971962 is the FDA 510(k) clearance record for OSTEO KIRSCHNER WIRES, a class II device, cleared for Osteonics Corp. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K971962.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260