Cleared Special

K143069 - HEMASORBPLUS press Resorable Hemostatic...

K143069 · Orthocon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
56d
Days
-
Risk

K143069 is an FDA 510(k) clearance for the HEMASORBPLUS press Resorable Hemostatic Bone Putty. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on December 22, 2014 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K143069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date December 22, 2014
Days to Decision 56 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 23
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K143069.
MONTAGE-QS Settable, Resorbable Hemostatic Bone
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HEMASORBPLUS Resorbable Hemostatic Bone Putty
K153317 · Orthocon, Inc. · Nov 2016
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K152005 · Orthocon, Inc. · Oct 2015
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · Orthocon, Inc. · Oct 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
K140117 · Orthocon, Inc. · Feb 2014
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
K123243 · Orthocon, Inc. · Apr 2013