510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113079Substantially Equivalent

Synthes Hemostatic Bone Putty

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

K113079 is the FDA 510(k) clearance record for SYNTHES HEMOSTATIC BONE PUTTY, cleared for Synthes (Usa) Products, LLC/Norian Corporation on under FDA product code MTJ (Wax, Bone). FDA records list one 510(k) clearance for Synthes (Usa) Products, LLC/Norian Corporation. As of , FDA records show 2 recalls naming K113079.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
Synthes (Usa) Products, LLC/Norian Corporation 1230 Wilson Dr., 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