The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Hercules Suture Anchor System.
| Device ID | K201636 |
| 510k Number | K201636 |
| Device Name: | Hercules Suture Anchor System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2020-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021860244 | K201636 | 000 |
| 00810021860237 | K201636 | 000 |
| 00810021860220 | K201636 | 000 |
| 00810021860213 | K201636 | 000 |
| 00810021860206 | K201636 | 000 |
| 00810021860190 | K201636 | 000 |
| 00810021860183 | K201636 | 000 |
| 00810021860176 | K201636 | 000 |
| 00810021860169 | K201636 | 000 |