The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Hercules Syndesmosis Implant System.
| Device ID | K220260 |
| 510k Number | K220260 |
| Device Name: | Hercules Syndesmosis Implant System |
| Classification | Washer, Bolt Nut |
| Applicant | In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021861470 | K220260 | 000 |