510(k) K201497
K201497 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) for the device "EVOS Cabling System". The FDA issued a decision of Substantially Equivalent on Oct 28, 2020. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2020
- Date Received
- Jun 5, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type
- 510(k)