SANTORINI SPINAL SYSTEM

Spinal Vertebral Body Replacement Device

K2M, INC.

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

Pre-market Notification Details

• Device ID: K111294
• 510k Number: K111294
• Device Name: SANTORINI SPINAL SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• 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: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-10
• Decision Date: 2012-01-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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