Erisma® LP Spinal Fixation System

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 Spinal Fixation System.

Pre-market Notification Details

• Device ID: K170163
• 510k Number: K170163
• Device Name: Erisma® LP Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: CLARIANCE SAS 18 Rue Robespierre Beaurains, FR 62217
• Contact: Pascal Rokegem
• Correspondent: Janice Hogan; HOGAN LOVELLS US LLP 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-18
• Decision Date: 2017-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700780627400	K170163	000
03700780627332	K170163	000
03700780627318	K170163	000
03700780627264	K170163	000
03700780626403	K170163	000
03700780626397	K170163	000
03700780626359	K170163	000
03700780626342	K170163	000
03700780623723	K170163	000
03700780616190	K170163	000
03700780616183	K170163	000
03700780616176	K170163	000
03700780627363	K170163	000
03700780627370	K170163	000
03700780626427	K170163	000
03700780626335	K170163	000
03700780626311	K170163	000
03700780627394	K170163	000
03700780627387	K170163	000
03700780627356	K170163	000
03700780627349	K170163	000
03700780627325	K170163	000
03700780627301	K170163	000
03700780626328	K170163	000
03700780627417	K170163	000
03700780611683	K170163	000