Cleared Traditional

C.S.M. HIP (K862752) - FDA 510(k) Clearance

K862752 · Protek, Inc. · Orthopedic device
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Aug 1986
Decision
16d
Days
-
Risk

K862752 is an FDA 510(k) clearance for the C.S.M. HIP.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 Protek, Inc. devices

Submission Details

510(k) Number K862752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 07, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -