510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103822Substantially Equivalent

Synthes Hemostatic Bone Putty (Hbp)

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103822 is the FDA 510(k) clearance record for SYNTHES HEMOSTATIC BONE PUTTY (HBP), cleared for Synthes USA Products, LLC on under FDA product code MTJ (Wax, Bone). FDA records list 479 510(k) clearances for Synthes USA Products, LLC, from to . As of , FDA records show one recall naming K103822.

Clearance record

Decision date
Received
(140 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
Synthes USA Products, LLC 1230 Wilson Blvd., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTJ

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