Erisma® LP MIS

Thoracolumbosacral Pedicle Screw System

CLARIANCE SAS

The following data is part of a premarket notification filed by Clariance Sas with the FDA for Erisma® Lp Mis.

Pre-market Notification Details

• Device ID: K162367
• 510k Number: K162367
• Device Name: Erisma® LP MIS
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: CLARIANCE SAS 18, Rue Robespierre Beaurains, FR 62217
• Contact: Pascal Rokegem
• Correspondent: Janice M. Hogan; Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-23
• Decision Date: 2016-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700780638833	K162367	000
03700780634576	K162367	000
03700780634569	K162367	000
03700780630110	K162367	000
03700780630165	K162367	000
03700780644100	K162367	000
03700780644094	K162367	000
03700780644087	K162367	000