The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee Unlimited.
| Device ID | K073615 |
| 510k Number | K073615 |
| Device Name: | BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Per Persson |
| Correspondent | Per Persson BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-09-05 |
| Summary: | summary |