The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Zone Specific Aim.
| Device ID | K220186 |
| 510k Number | K220186 |
| Device Name: | Zone Specific AIM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CONMED Corporation 525 French Road Utica, NY 13502 |
| Contact | Orjada Dervishleri |
| Correspondent | Orjada Dervishleri ConMed Corporation 11311 Concept Boulevard Largo, FL 33773 -4908 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854649906 | K220186 | 000 |
| 20845854649890 | K220186 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZONE SPECIFIC AIM 90704280 not registered Live/Pending |
Conmed Corporation 2021-05-11 |