The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Dash Hip.
| Device ID | K110021 |
| 510k Number | K110021 |
| Device Name: | DASH HIP |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-10-18 |
| Summary: | summary |