510(k) K200095 ยท OLO Orthopedic Stereotaxic Instrument
Streamline Navigated Instruments
| Applicant | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Jan 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN
26-FTAP-30-MDN
26-FTAP-35-MDN
26-FTAP-40-MDN
26-FTAP-40-MDN
26-FTAP-45-MDN
26-S-FINDER-MDN
Components of a surgical navigation de Open, Classified |
OLO | None listed |
| Oct 27, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog Nos.
04-CANNDRILL-MDN
04-CANNTAP-40-MDN
04-CANNTAP-45-MDN
04-CANNTAP-55-MDN
04-CANNTAP-65-MDN
04-CANNTAP-75-MDN
04-CANNTAP-85-MDN
04-CTAP-TT-65-MDN
04- Terminated |
OLO | None listed |
| Oct 27, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline TL Navigation System, Catalog Nos.
02-C-TAP-55-MDN
02-C-TAP-60-L-MDN
02-C-TAP-65-L-MDN
02-C-TAP-65-MDN
02-C-TAP-75-L-MDN
02-C-TAP-85-L-MDN
02-C-TAP-85-MDN
02-C-TAP-95-L-MDN
02-RS-INS-C-MD Terminated |
OLO | None listed |
| Sep 11, 2020 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog numbers
04-CANNDRILL-MDN
04-CANNTAP-40-MDN
04-CANNTAP-45-MDN
04-CANNTAP-55-MDN
04-CANNTAP-65-MDN
04-CANNTAP-75-MDN
04-CANNTAP-85-MDN
04-CTAP-TT-65-MDN
Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.