510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931737Substantially Equivalent

Hedleyl Intramedullary Preparation Brush

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

K931737 is the FDA 510(k) clearance record for HEDLEYL INTRAMEDULLARY PREPARATION BRUSH, a class I device, cleared for Synvasive Technology, Inc. on under FDA product code HTZ (Instrument, Cutting, Orthopedic). FDA records list 10 510(k) clearances for Synvasive Technology, Inc., from to . As of , FDA records show no recalls naming K931737.

Clearance record

Decision date
Received
(275 days to decision)
Product code
HTZ Instrument, Cutting, Orthopedic
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Synvasive Technology, Inc. 11328 Sunrise Gold Cir., Rancho Cordova CA
510(k) summary
Summary
Third party review
No

Clearances, product code HTZ

Trailing 12 months

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

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