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 |