MODIFICATION TO TENOR SPINAL SYSTEM-PLATES

Orthosis, Spondylolisthesis Spinal Fixation

SOFAMOR DANEK USA,INC.

The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Modification To Tenor Spinal System-plates.

Pre-market Notification Details

• Device ID: K991364
• 510k Number: K991364
• Device Name: MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: SOFAMOR DANEK USA,INC. 1730 PENNSYLVANIA AVE. Washington, DC 20006
• Contact: Bailey Lipscomb
• Correspondent: Bailey Lipscomb; SOFAMOR DANEK USA,INC. 1730 PENNSYLVANIA AVE. Washington, DC 20006
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-20
• Decision Date: 1999-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00673978971070	K991364	000
00673978950037	K991364	000
00673978948072	K991364	000
00673978928807	K991364	000