Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K193307
HIP7 · Brainlab AG · decided 2020-06-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 52858-02 | Smith & Nephew, Inc. | OLO | 00885556909331 |
| Bone Fixator 2-Pin X-Press | 52429 | Brainlab SE | OLO | 04056481005955 |
| Bl Pointer Straight-Extended | 52781A | Brainlab SE | HAW | 04056481002152 |
| Bone Fixator 1-Pin, X-Press Size-S | 52421B | Brainlab SE | OLO | 04056481002374 |
| (unnamed) | 52855-34 | Smith & Nephew, Inc. | OLO | 00885556909416 |
| (unnamed) | 52876B | Smith & Nephew, Inc. | OLO | 00885556909386 |
| Reference Star T-Geometry, X-Press | 52412 | Brainlab SE | OLO | 04056481006006 |
| (unnamed) | 52855-40 | Smith & Nephew, Inc. | OLO | 00885556909423 |
| (unnamed) | 52312 | Smith & Nephew, Inc. | OLO | 00885556908921 |
| (unnamed) | 52858-01 | Smith & Nephew, Inc. | OLO | 00885556909317 |
| (unnamed) | 52856B | Smith & Nephew, Inc. | OLO | 00885556909393 |
| HIP7 | 7.0 | Brainlab SE | OLO | 04056481141981 |
| (unnamed) | 52781A | Smith & Nephew, Inc. | OLO | 00885556909447 |
| (unnamed) | 52855-65 | Smith & Nephew, Inc. | OLO | 00885556909430 |
| (unnamed) | 52781-10 | Smith & Nephew, Inc. | OLO | 00885556909362 |
| BL 3.2MM PINDRIVER (AO INTERFACE) | 54932A | Brainlab SE | OLO | 04056481094928 |
| Reference Array T-Geometry, X-Press | 52410A | Brainlab SE | OLO | 04056481002404 |
| (unnamed) | 55085 | Smith & Nephew, Inc. | OLO | 00885556909348 |