Cleared Traditional

K041363 - AOC BONE WAX

K041363 · Ceremed , Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
67d
Days
-
Risk

K041363 is an FDA 510(k) clearance for the AOC BONE WAX. Classified as Wax, Bone (product code MTJ).

Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 27, 2004 after a review of 67 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 - K041363

510(k) Number K041363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2004
Decision Date July 27, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 26
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