Cleared Traditional

K943277 - LINK SADDLE PROTHESIS (FDA 510(k) Clearance)

K943277 · Turnkey Intergration USA, Inc. · General & Plastic Surgery device
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Jan 1995
Decision
203d
Days
-
Risk

K943277 is an FDA 510(k) clearance for the LINK SADDLE PROTHESIS.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 26, 1995 after a review of 203 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.

View all Turnkey Intergration USA, Inc. devices

Submission Details

510(k) Number K943277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date January 26, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 114d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -