CHESAPEAKE SPINAL SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

K2M, INC.

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

Pre-market Notification Details

• Device ID: K120031
• 510k Number: K120031
• Device Name: CHESAPEAKE SPINAL SYSTEM
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-04
• Decision Date: 2012-03-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857028616	K120031	000
10888857027947	K120031	000
10888857027930	K120031	000
10888857027848	K120031	000
10888857027831	K120031	000
10888857027824	K120031	000
10888857027732	K120031	000
10888857027725	K120031	000
10888857027718	K120031	000
10888857027626	K120031	000
10888857027619	K120031	000
10888857027602	K120031	000
10888857027510	K120031	000
10888857027503	K120031	000
10888857027497	K120031	000
10888857025431	K120031	000
10888857027954	K120031	000
10888857028043	K120031	000
10888857028050	K120031	000
10888857028609	K120031	000
10888857028593	K120031	000
10888857028500	K120031	000
10888857028494	K120031	000
10888857028487	K120031	000
10888857028395	K120031	000
10888857028388	K120031	000
10888857028371	K120031	000
10888857028289	K120031	000
10888857028272	K120031	000
10888857028265	K120031	000
10888857028173	K120031	000
10888857028166	K120031	000
10888857028159	K120031	000
10888857028067	K120031	000
10888857025394	K120031	000