The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Hip7.
| Device ID | K193307 |
| 510k Number | K193307 |
| Device Name: | HIP7 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Cherita James |
| Correspondent | Cherita James M Squared Associates Inc. 575 8th Ave Suite 1212 New York, NY 10018 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556909416 | K193307 | 000 |
| 00885556909331 | K193307 | 000 |
| 00885556909348 | K193307 | 000 |
| 00885556909362 | K193307 | 000 |
| 00885556909386 | K193307 | 000 |
| 00885556909423 | K193307 | 000 |
| 00885556909430 | K193307 | 000 |
| 00885556909447 | K193307 | 000 |
| 00885556908921 | K193307 | 000 |
| 00885556909317 | K193307 | 000 |