510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K193052Substantially Equivalent

HBP6 Settable, Resorbable Hemostatic Bone Paste

Orthocon, Inc., Irvington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193052 is the FDA 510(k) clearance record for HBP6 Settable, Resorbable Hemostatic Bone Paste, cleared for Orthocon, Inc. on under FDA product code MTJ (Wax, Bone). FDA records list 39 510(k) clearances for Orthocon, Inc., from to . As of , FDA records show no recalls naming K193052.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
Orthocon, Inc. 1 Bridge St., Suite 121, Irvington NY
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