CASPIAN SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

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: K092640
• 510k Number: K092640
• Device Name: CASPIAN SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Contact: Richard W Woods
• Correspondent: Richard W Woods; K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-27
• Decision Date: 2009-11-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857012301	K092640	000
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