Cleared Traditional

LUMBAR NERVE ROOT SHIELD (K780706) - FDA 510(k) Clearance

K780706 · Heyer Schulte Corp. · Neurology device
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Sep 1978
Decision
135d
Days
-
Risk

K780706 is an FDA 510(k) clearance for the LUMBAR NERVE ROOT SHIELD.

Submitted by Heyer Schulte Corp. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Heyer Schulte Corp. devices

Submission Details

510(k) Number K780706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1978
Decision Date September 07, 1978
Days to Decision 135 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 148d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -