The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Uni-knee 2.0.
| Device ID | K080678 |
| 510k Number | K080678 |
| Device Name: | UNI-KNEE 2.0 |
| 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 | 2008-03-10 |
| Decision Date | 2008-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481138806 | K080678 | 000 |
| 04056481006860 | K080678 | 000 |