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 |
Trademark Results [Erisma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERISMA 79093033 4152212 Live/Registered |
CLARIANCE S.A.S 2011-01-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.