510(k) K183060 · KWQ Appliance, Fixation, Spinal Intervertebral Body
CervAlign Anterior Cervical Plate System
| Applicant | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Marquette MI, US |
| Decision | Substantially Equivalent, Jan 17, 2019 |
| Received | Nov 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.