Cleared Traditional

K931488 - KSF SPINAL FIXATOR
(FDA 510(k) Clearance)

K931488 · Franklin Medical USA, Inc. · General & Plastic Surgery device
Jan 1994
Decision
302d
Days
—
Risk

K931488 is an FDA 510(k) clearance for the KSF SPINAL FIXATOR..

Submitted by Franklin Medical USA, Inc. (Concord, US). The FDA issued a Cleared decision on January 21, 1994, 302 days after receiving the submission on March 25, 1993.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K931488 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 25, 1993
Decision Date January 21, 1994
Days to Decision 302 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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Device Class —