AERIAL™ Interspinous Fixation

Spinous Process Plate

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Aerial™ Interspinous Fixation.

Pre-market Notification Details

• Device ID: K180817
• 510k Number: K180817
• Device Name: AERIAL™ Interspinous Fixation
• Classification: Spinous Process Plate
• Applicant: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker; Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Product Code: PEK
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-29
• Decision Date: 2018-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095717112	K180817	000
00889095716979	K180817	000
00889095716962	K180817	000
00889095716955	K180817	000
00889095716948	K180817	000
00889095716931	K180817	000
00889095716924	K180817	000
00889095716917	K180817	000
00889095716900	K180817	000
00889095716894	K180817	000
00889095716986	K180817	000
00889095716993	K180817	000
00889095717006	K180817	000
00889095717105	K180817	000
00889095717082	K180817	000
00889095717075	K180817	000
00889095717068	K180817	000
00889095717051	K180817	000
00889095717044	K180817	000
00889095717037	K180817	000
00889095717020	K180817	000
00889095717013	K180817	000
00889095716887	K180817	000