510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K161489Substantially Equivalent

Syntorr K-wire and Pin System

Syntorr, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161489 is the FDA 510(k) clearance record for Syntorr K-wire and Pin System, a class II device, cleared for Syntorr, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list one 510(k) clearance for Syntorr, Inc. As of , FDA records show no recalls naming K161489.

Clearance record

Decision date
Received
(107 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Syntorr, Inc. 1157 Harker Ave., Palo Alto CA
510(k) summary
Summary PDF
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