Cleared Traditional

K130309 - RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
(FDA 510(k) Clearance)

K130309 · Biomet Microfixation · Neurology

Jun 2013

Decision

130d

Days

Class 2

Risk

K130309 is an FDA 510(k) clearance for the RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM, a Cover, Burr Hole (Class II — Special Controls, product code GXR), submitted by Biomet Microfixation (Bartlett, US). The FDA issued a Cleared decision on June 17, 2013, 130 days after receiving the submission on February 7, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5250.

Submission Details

510(k) Number	K130309 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2013
Decision Date	June 17, 2013
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF