Cleared Traditional

K943277 - LINK SADDLE PROTHESIS

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

FDA 510(k) Submission Details - K943277

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -