MOUNTAINEER OCT SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Oct Spinal System.

Pre-market Notification Details

• Device ID: K110353
• 510k Number: K110353
• Device Name: MOUNTAINEER OCT SPINAL SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Luke Bulino
• Correspondent: Luke Bulino; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-07
• Decision Date: 2011-04-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034466392	K110353	000
10705034290416	K110353	000
10705034290409	K110353	000
10705034290393	K110353	000
10705034290386	K110353	000
10705034290379	K110353	000
10705034290362	K110353	000
10705034290355	K110353	000
10705034290348	K110353	000
10705034290331	K110353	000
10705034290324	K110353	000
10705034290317	K110353	000
10705034290300	K110353	000
10705034290294	K110353	000
10705034290423	K110353	000
10705034290430	K110353	000
10705034290560	K110353	000
10705034290553	K110353	000
10705034290546	K110353	000
10705034290539	K110353	000
10705034290522	K110353	000
10705034290515	K110353	000
10705034290508	K110353	000
10705034290492	K110353	000
10705034290485	K110353	000
10705034290478	K110353	000
10705034290461	K110353	000
10705034290454	K110353	000
10705034290447	K110353	000
10705034290287	K110353	000