The following data is part of a premarket notification filed by Morpheus Ag with the FDA for Rebellion; Phantom Multi-bite Kerrison Rongeur.
| Device ID | K221818 |
| 510k Number | K221818 |
| Device Name: | Rebellion; Phantom Multi-Bite Kerrison Rongeur |
| Classification | Rongeur, Manual |
| Applicant | Morpheus AG Bahnhofstraße 18 Spaichingen, DE 78549 |
| Contact | Timo Rack |
| Correspondent | Timo Rack Morpheus AG Bahnhofstraße 18 Spaichingen, DE 78549 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-23 |
| Decision Date | 2022-10-07 |