Cleared Special

K082491 - OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE

K082491 · Ceremed , Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
27d
Days
-
Risk

K082491 is an FDA 510(k) clearance for the OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTE.... Classified as Wax, Bone (product code MTJ).

Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 24, 2008 after a review of 27 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 Ceremed , Inc. devices

FDA 510(k) Submission Details - K082491

510(k) Number K082491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date September 24, 2008
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K082491.
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
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ORTHOSTAT
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OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
K060987 · Cp Medical · Nov 2006
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K052528 · Ceremed , Inc. · Oct 2005