STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM— 510(k) K133374

Substantially Equivalent

Pioneer Surgical Technology, Inc. (Rti Surgical, I

FDA 510(k) clearance K133374 for STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM, Substantially Equivalent on 2014-03-19. Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, I.

Clearance details

Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, I
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2013-11-01
Decision date: 2014-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.