Cleared Traditional

K102071 - OSTENE CT, AOC CT, OSTEOTENE, CERETENE

K102071 · Ceremed , Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
77d
Days
-
Risk

K102071 is an FDA 510(k) clearance for the OSTENE CT, AOC CT, OSTEOTENE, CERETENE. Classified as Wax, Bone (product code MTJ).

Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 8, 2010 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ceremed , Inc. devices

FDA 510(k) Submission Details - K102071

510(k) Number K102071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2010
Decision Date October 08, 2010
Days to Decision 77 days
Submission Type Traditional
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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 40
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K091636 · Ceremed , Inc. · Jun 2009
ORTHOSTAT
K091121 · Orthocon, Inc. · Apr 2009
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
K082491 · Ceremed , Inc. · Sep 2008