MESA SPINAL SYSTEM (KEYSTONE RODS)

Orthosis, Spinal Pedicle Fixation

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Mesa Spinal System (keystone Rods).

Pre-market Notification Details

• Device ID: K110991
• 510k Number: K110991
• Device Name: MESA SPINAL SYSTEM (KEYSTONE RODS)
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: K2M, INC. 751 MILLER DR.,SE SUITE F-1 Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DR.,SE SUITE F-1 Leesburg, VA 20175
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-08
• Decision Date: 2011-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857144637	K110991	000
10888857144590	K110991	000
10888857144309	K110991	000
10888857144248	K110991	000
10888857144040	K110991	000