CHESAPEAKE (CERVICAL COMPONENTS)

Intervertebral Fusion Device With Integrated Fixation, Cervical

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Chesapeake (cervical Components).

Pre-market Notification Details

• Device ID: K111439
• 510k Number: K111439
• Device Name: CHESAPEAKE (CERVICAL COMPONENTS)
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• 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: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-24
• Decision Date: 2011-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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