EVOS Cabling System— 510(k) K201497
Substantially EquivalentPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
FDA 510(k) clearance K201497 for EVOS Cabling System, Substantially Equivalent on 2020-10-28. Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Device class: 2.
Clearance details
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marquette, MI, US
Recent devices under product code JDQ
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Adverse events under product code JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
Source: openFDA MAUDE database, through . 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.