510(k) K191507 · OLO Orthopedic Stereotaxic Instrument
Intellijoint® Navigation System
| Applicant | Intellijoint Surgical, Inc., Waterloo, CA |
| Decision | Substantially Equivalent, Oct 1, 2019 |
| Received | Jun 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Intellijoint Surgical, Inc. Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249 Open, Classified |
OLO | None listed |
| Feb 11, 2020 | Intellijoint Surgical, Inc. Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-oper Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.