The following data is part of a premarket notification filed by Clariance with the FDA for Aggeris™-c.
| Device ID | K220182 |
| 510k Number | K220182 |
| Device Name: | Aggeris™-C |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Clariance 18, Rue Robespierre Beaurains, FR 62217 |
| Contact | Mélody La Porte |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-03-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AGGERIS 88564641 not registered Live/Pending |
CLARIANCE SAS 2019-08-02 |