Cleared Traditional

AVAFLEX VERTEBRAL BALLOON SYSTEM

K131824 · Care Fusion · Orthopedic

Oct 2013

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K131824 is an FDA 510(k) clearance for the AVAFLEX VERTEBRAL BALLOON SYSTEM, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on October 3, 2013, 105 days after receiving the submission on June 20, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K131824 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2013
Decision Date	October 03, 2013
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).