The following data is part of a premarket notification filed by Exotoe Llc with the FDA for Exotoe Staple.
| Device ID | K172205 |
| 510k Number | K172205 |
| Device Name: | ExoToe Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | ExoToe LLC Po Box 548 Grimes, IA 50111 |
| Contact | Avi Roop |
| Correspondent | Jerzy Wojcik EdgeOne Medical 455 N Campbell Ave Suite #2N Chicago, IL 60612 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-21 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B065EX075 | K172205 | 000 |
| B605SZR001 | K172205 | 000 |
| B605EX055 | K172205 | 000 |
| B605EX060 | K172205 | 000 |
| B605EX065 | K172205 | 000 |
| B605EX070 | K172205 | 000 |
| B605EX075 | K172205 | 000 |
| B065EX055 | K172205 | 000 |
| B065EX060 | K172205 | 000 |
| B065EX065 | K172205 | 000 |
| B065EX070 | K172205 | 000 |
| B605FCP001 | K172205 | 000 |