510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061131Substantially Equivalent

Dbx-H Hemostatic Demineralized Bone Matrix Putty

Orthocon, Inc., Colts Neck NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061131 is the FDA 510(k) clearance record for DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY, a class II device, cleared for Orthocon, Inc. on under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)). FDA records list 39 510(k) clearances for Orthocon, Inc., from to . As of , FDA records show no recalls naming K061131.

Clearance record

Decision date
Received
(290 days to decision)
Product code
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Orthocon, Inc. 167 Stone Hill Rd., Colts Neck NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBP

Trailing 12 months

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

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