Cleared Special

K063330 - ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

K063330 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
19d
Days
-
Risk

K063330 is an FDA 510(k) clearance for the ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Colts Neck, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 19 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

FDA 510(k) Submission Details - K063330

510(k) Number K063330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2006
Decision Date November 22, 2006
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 40
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