The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Hip Unlimited, Ci Hip Unlimited.
| Device ID | K083483 |
| 510k Number | K083483 |
| Device Name: | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Michael Hottner |
| Correspondent | Michael Hottner 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 | 2008-11-24 |
| Decision Date | 2009-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481006198 | K083483 | 000 |
| 04056481002015 | K083483 | 000 |
| 04056481001988 | K083483 | 000 |
| 04056481001971 | K083483 | 000 |
| 04056481001964 | K083483 | 000 |
| 04056481001940 | K083483 | 000 |
| 04056481001933 | K083483 | 000 |
| 04056481001926 | K083483 | 000 |
| 04056481001902 | K083483 | 000 |
| 04056481002039 | K083483 | 000 |
| 04056481002114 | K083483 | 000 |
| 04056481002121 | K083483 | 000 |
| 04056481006181 | K083483 | 000 |
| 04056481005757 | K083483 | 000 |
| 04056481005719 | K083483 | 000 |
| 04056481003524 | K083483 | 000 |
| 04056481002411 | K083483 | 000 |
| 04056481002312 | K083483 | 000 |
| 04056481002183 | K083483 | 000 |
| 04056481002169 | K083483 | 000 |
| 04056481001896 | K083483 | 000 |