Cleared Traditional

K850803 - NAIL SPLINT

K850803 · Inro Medical Designs, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
231d
Days
-
Risk

K850803 is an FDA 510(k) clearance for the NAIL SPLINT. Classified as Prosthesis, Nail (product code MQZ).

Submitted by Inro Medical Designs, Inc. (Desoto, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 231 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 Inro Medical Designs, Inc. devices

FDA 510(k) Submission Details - K850803

510(k) Number K850803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1985
Decision Date October 16, 1985
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

MQZ Device Classification - Class 0,

Product Code MQZ Prosthesis, Nail
Device Class -