Cleared Traditional

K912843 - FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
(FDA 510(k) Clearance)

K912843 · Flexmedics · Orthopedic device

Sep 1991

Decision

90d

Days

Class 1

Risk

K912843 is an FDA 510(k) clearance for the FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE. This device is classified as a Probe (Class I - General Controls, product code HXB).

Submitted by Flexmedics (Minneapolis, US). The FDA issued a Cleared decision on September 24, 1991, 90 days after receiving the submission on June 26, 1991.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K912843 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 1991
Decision Date	September 24, 1991
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement