The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Navigation Software Hip-universal; Navigation Software Hip Thr-aesculap.
| Device ID | K122011 |
| 510k Number | K122011 |
| Device Name: | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP |
| 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 | 2012-07-09 |
| Decision Date | 2012-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481005368 | K122011 | 000 |
| 04056481002077 | K122011 | 000 |
| 04056481002060 | K122011 | 000 |
| 04056481002053 | K122011 | 000 |
| 04056481002046 | K122011 | 000 |
| 04056481002022 | K122011 | 000 |
| 04056481002008 | K122011 | 000 |
| 04056481001995 | K122011 | 000 |
| 04056481001957 | K122011 | 000 |
| 04056481001889 | K122011 | 000 |
| 04056481001872 | K122011 | 000 |
| 04056481002084 | K122011 | 000 |
| 04056481002091 | K122011 | 000 |
| 04056481003586 | K122011 | 000 |
| 04056481003562 | K122011 | 000 |
| 04056481003494 | K122011 | 000 |
| 04056481003470 | K122011 | 000 |
| 04056481003210 | K122011 | 000 |
| 04056481002688 | K122011 | 000 |
| 04056481002671 | K122011 | 000 |
| 04056481002657 | K122011 | 000 |
| 04056481002206 | K122011 | 000 |
| 04056481002107 | K122011 | 000 |
| 04056481122805 | K122011 | 000 |