Cleared Traditional

NAIL SPLINT (K850803) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code MQZ Prosthesis, Nail
Device Class -