OsteoVation Impact— 510(k) K162864

Clearance details

Applicant

Skeletal Kinetics, LLC

Product code

Code GXP

Device class

Class 2

Regulation

21 CFR 882.5300

Advisory panel

Neurology

Date received

2016-10-13

Decision date

2017-01-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cupertino, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162864.