Cleared Traditional

K060987 - OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31

K060987 · Cp Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
206d
Days
-
Risk

K060987 is an FDA 510(k) clearance for the OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31. Classified as Wax, Bone (product code MTJ).

Submitted by Cp Medical (Buford, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 206 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 - K060987

510(k) Number K060987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date November 02, 2006
Days to Decision 206 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
91d slower than avg
Panel avg: 115d · This submission: 206d
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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