The following data is part of a premarket notification filed by Hoogland Spine Products, Gmbh with the FDA for Maxmorespine Bipolar Electrodes.
| Device ID | K211173 |
| 510k Number | K211173 |
| Device Name: | Maxmorespine Bipolar Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Hoogland Spine Products, GmbH Feringastrasse 4 Munich, DE D-85774 |
| Contact | Jaap Hoogland |
| Correspondent | Kenneth Kleinhenz Hoogland Spine Products, GmbH Feringastrasse 4 Munich, DE D-85774 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-20 |
| Decision Date | 2022-06-23 |