FDA applicant
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
FDA records 16 decisions for Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, MI) from 2015 to 2020: 16 510(k) clearances. Most are in product codes JDQ (Cerclage, Fixation) and OVE (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 6 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.”, “Pioneer Surgical Technology, Inc., Dba Rti Surgical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)’s devices, and how often a recall has named them.
FDA decisions per year
5in 2020
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Pioneer Surgical Technology, Inc. (Dba…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Pioneer”
FDA records each applicant name separately; these may or may not be the same firm.