Valeo® C+CSC With Lumen Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

Amedica Corp.

The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo® C+csc With Lumen Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K173453
• 510k Number: K173453
• Device Name: Valeo® C+CSC With Lumen Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Amedica Corp. 1885 W 2100 S Salt Lake City, UT 84119
• Contact: Jason Parberry
• Correspondent: Shanna Ryan; Shanna Ryan 63 East 11400 South 192 Sandy, UT 84070
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-06
• Decision Date: 2018-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841732154759	K173453	000
00841732154865	K173453	000
00841732154810	K173453	000
00841732154803	K173453	000
00841732154797	K173453	000
00841732154780	K173453	000
00841732154773	K173453	000
00841732154766	K173453	000
00841732145566	K173453	000
00841732145559	K173453	000
00841732145542	K173453	000
00841732145535	K173453	000
00841732145528	K173453	000
00841732154872	K173453	000
00841732154889	K173453	000
00841732154742	K173453	000
00841732154735	K173453	000
00841732160217	K173453	000
00841732155008	K173453	000
00841732154988	K173453	000
00841732154971	K173453	000
00841732154964	K173453	000
00841732154933	K173453	000
00841732154926	K173453	000
00841732154919	K173453	000
00841732154902	K173453	000
00841732154896	K173453	000
00841732145511	K173453	000