510(k) K201379
K201379 is an FDA 510(k) premarket notification submitted by Glw, Inc. for the device "Artemis Proximal Femoral Nail System". The FDA issued a decision of Substantially Equivalent on Feb 19, 2021. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Glw, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 19, 2021
- Date Received
- May 26, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type
- 510(k)