510(k) K183605 ยท OLO Orthopedic Stereotaxic Instrument
Spine & Trauma Navigation
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2020 | Brainlab AG Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A) Terminated |
OLO | None listed |
| Jul 16, 2020 | Brainlab AG BRAINLAB Curve;
Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905
UDI (GTIN) for Curve: 04056481138011 Terminated |
OLO | None listed |
| Jul 16, 2020 | Brainlab AG BRAINLAB Kick 2;
Model/catalogue (article) numbers for Kick: 18170; 18070
UDI (GTIN) for Kick: 04056481006655 Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.