The following data is part of a premarket notification filed by Geister Medizintechnik Gmbh with the FDA for Geister Retractor For Neuro - And Spine Surgery.
| Device ID | K180610 |
| 510k Number | K180610 |
| Device Name: | Geister Retractor For Neuro - And Spine Surgery |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | Geister Medizintechnik GmbH Forhenstrasse 2 Tuttlingen, DE 78532 |
| Contact | Christian Grotzinger |
| Correspondent | Christian Grotzinger Geister Medizintechnik GmbH Forhenstrasse 2 Tuttlingen, DE 78532 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-08 |
| Decision Date | 2018-08-29 |
| Summary: | summary |