Cleared Traditional

K024372 - CP MEDICAL BONE WAX

K024372 · Cp Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
170d
Days
-
Risk

K024372 is an FDA 510(k) clearance for the CP MEDICAL BONE WAX. Classified as Wax, Bone (product code MTJ).

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on June 19, 2003 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K024372

510(k) Number K024372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2002
Decision Date June 19, 2003
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

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 K024372.
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440 · Ceremed , Inc. · Mar 2005
SHARPOINT LUKENS BONE WAX
K050292 · Surgical Specialties Corp · Mar 2005
AOC BONE WAX
K041363 · Ceremed , Inc. · Jul 2004
AESCULAP BONE WAX
K000021 · Aesculap, Inc. · Mar 2000
AUTO SUTURE BONE WAX
K971680 · United States Surgical, A Division of Tyco Healthc · Oct 1997