CASPIAN

Appliance, Fixation, Spinal Interlaminal

K2M, INC.

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

Pre-market Notification Details

• Device ID: K113654
• 510k Number: K113654
• Device Name: CASPIAN
• 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: 2011-12-12
• Decision Date: 2012-01-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857016521	K113654	000
10888857016354	K113654	000
10888857016361	K113654	000
10888857016378	K113654	000
10888857016385	K113654	000
10888857016392	K113654	000
10888857016408	K113654	000
10888857016415	K113654	000
10888857016422	K113654	000
10888857016439	K113654	000
10888857016446	K113654	000
10888857016453	K113654	000
10888857016460	K113654	000
10888857016484	K113654	000
10888857016507	K113654	000
10888857016347	K113654	000