SP-FIX SPINOUS PROCESS FIXATION PLATE

Appliance, Fixation, Spinal Interlaminal

GLOBUS MEDICAL, INC.

The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Sp-fix Spinous Process Fixation Plate.

Pre-market Notification Details

• Device ID: K102195
• 510k Number: K102195
• Device Name: SP-FIX SPINOUS PROCESS FIXATION PLATE
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Contact: Kelly J Baker
• Correspondent: Kelly J Baker; GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-04
• Decision Date: 2011-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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