SUMIT OCT SPINAL SYSTEM AND 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 Sumit Oct Spinal System And Mountaineer Oct Spinal System.

Pre-market Notification Details

• Device ID: K042508
• 510k Number: K042508
• Device Name: SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Sharon Starowicz
• Correspondent: Sharon Starowicz; 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: 2004-09-15
• Decision Date: 2004-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034156767	K042508	000
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