ALEUTIAN SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

K2M, INC.

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

Pre-market Notification Details

• Device ID: K113138
• 510k Number: K113138
• Device Name: ALEUTIAN SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• 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: MAX
• Subsequent Product Code: MQP
• Subsequent Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-25
• Decision Date: 2012-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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