510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961522Substantially Equivalent

Kirschner Wire (K-Wire) and Steinmann Pin

Synvasive Technology, Inc., El Dorado CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961522 is the FDA 510(k) clearance record for KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN, a class II device, cleared for Synvasive Technology, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 10 510(k) clearances for Synvasive Technology, Inc., from to . As of , FDA records show no recalls naming K961522.

Clearance record

Decision date
Received
(154 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Synvasive Technology, Inc. 4925 Robert J Mathews Pkwy., El Dorado CA
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