Tesera-k ALIF System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Kyocera Medical Technologies, Inc.

The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Tesera-k Alif System.

Pre-market Notification Details

• Device ID: K212980
• 510k Number: K212980
• Device Name: Tesera-k ALIF System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Kyocera Medical Technologies, Inc. 1200 California Street, Ste. 210 Redlands, CA 92374
• Contact: Scott Rucker
• Correspondent: Nathan Wright; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-17
• Decision Date: 2022-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841523151929	K212980	000
00841523151806	K212980	000
00841523151790	K212980	000
00841523151783	K212980	000
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00841523152025	K212980	000
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00841523151943	K212980	000