The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Erisma-lp Spinal Fixation System.
| Device ID | K153326 |
| 510k Number | K153326 |
| 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 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780637881 | K153326 | 000 |
| 03700780634385 | K153326 | 000 |
| 03700780618255 | K153326 | 000 |
| 03700780639199 | K153326 | 000 |