510(k) K150254 ยท KWP Appliance, Fixation, Spinal Interlaminal
Streamline OCT Occipito-Cervico-Thoracic System
| Applicant | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Marquette MI, US |
| Decision | Substantially Equivalent, Apr 28, 2015 |
| Received | Feb 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150254
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L)
Product Usage:
When intended to promote fusion of the cervical spine and occipitocervico-thoracic junctio Terminated |
KWP | None listed |
| May 26, 2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument. Terminated |
KWP | None listed |
| Mar 18, 2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.