The following data is part of a premarket notification filed by Exsomed Corp. with the FDA for Exsomed Innate Nanotm Lag Screw System.
| Device ID | K220892 |
| 510k Number | K220892 |
| Device Name: | ExsoMed INnate NanoTM Lag Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | ExsoMed Corp. 135 Columbia, Suite 201 Aliso Viejo, CA 92656 |
| Contact | Reinhold Toerek |
| Correspondent | Reinhold Toerek ExsoMed Corp. 135 Columbia, Suite 201 Aliso Viejo, CA 92656 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-04-27 |