The following data is part of a premarket notification filed by Sequel Medical Inc. with the FDA for Sequel External Fixation Device.
| Device ID | K202833 |
| 510k Number | K202833 |
| Device Name: | Sequel External Fixation Device |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Sequel Medical Inc. 12550 Biscayne Blvd Ste 110 North Miami, FL 33181 -2536 |
| Contact | Valentina Kamysheva |
| Correspondent | Valentina Kamysheva Sequel Medical Inc. 12550 Biscayne Blvd Ste 110 North Miami, FL 33181 -2536 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810071321726 | K202833 | 000 |
| 00810071321528 | K202833 | 000 |
| 00810071321511 | K202833 | 000 |
| 00810071321504 | K202833 | 000 |
| 00810071321160 | K202833 | 000 |
| 00810071321153 | K202833 | 000 |
| 00810071321146 | K202833 | 000 |
| 00810071321078 | K202833 | 000 |
| 00810071321061 | K202833 | 000 |
| 00810071321535 | K202833 | 000 |
| 00810071321542 | K202833 | 000 |
| 00810071321719 | K202833 | 000 |
| 00810071321702 | K202833 | 000 |
| 00810071321696 | K202833 | 000 |
| 00810071321689 | K202833 | 000 |
| 00810071321665 | K202833 | 000 |
| 00810071321573 | K202833 | 000 |
| 00810071321566 | K202833 | 000 |
| 00810071321559 | K202833 | 000 |
| 00810071321054 | K202833 | 000 |