CASPIAN SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Caspian Spinal System.

Pre-market Notification Details

• Device ID: K103232
• 510k Number: K103232
• Device Name: CASPIAN SPINAL SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-02
• Decision Date: 2011-01-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857014992	K103232	000
10888857014497	K103232	000
10888857014428	K103232	000
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10888857015029	K103232	000