Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K122011
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP · Brainlab AG · decided 2012-11-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Adapter For Cup Inserter | 41851C | Brainlab SE | OLO | 04056481003210 |
| Pointer Sharp Tip For Hip | 41780D | Brainlab SE | OLO | 04056481003586 |
| Bl Offset Reamer Handle - Ao Fit (Rfid) | 52481-01A | Brainlab SE | OLO | 04056481002206 |
| Pointer, Sharp Tip | 41780F | Brainlab SE | OLO | 04056481003562 |
| Bl Impactor Universal Thread 3/8-24Unf | 52855-31 | Brainlab SE | OLO | 04056481002107 |
| Bl Offset Cup Impactor Universal | 52856A | Brainlab SE | OLO | 04056481001957 |
| Bl Impactor Universal Thread M8X1 | 52855-38 | Brainlab SE | OLO | 04056481002046 |
| Drill Guide Tube 3.2 X 45 Mm | 41839-26 | Brainlab SE | OLO | 04056481003470 |
| Drill Guide Tube 2.5 X 45 Mm | 41839-24 | Brainlab SE | OLO | 04056481003494 |
| Bl Impactor Universal Thread 1/4-28Unf | 52855-37 | Brainlab SE | OLO | 04056481002053 |
| Stem Verification Tool Extended | 52873B | Brainlab SE | OLO | 04056481001889 |
| Bl Impactor Universal Thread M8 | 52855-32 | Brainlab SE | OLO | 04056481002091 |
| Bl Impactor Universal Thread 5/16-24Unf | 52855-35 | Brainlab SE | OLO | 04056481002060 |
| Cup Reamer Adap Zimmer Full Hemisphere | 41879-02B | Brainlab SE | OLO | 04056481002688 |
| Bl Impactor Universal Nose Square 10.55 | 52855-62 | Brainlab SE | OLO | 04056481001995 |
| Cup Reamer Adapter ''Bl'' | 41879-04 | Brainlab SE | OLO | 04056481002657 |