510(k) K220244
K220244 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech for the device "DVR® Crosslock Wrist Spanning Plate (131849181)". The FDA issued a decision of Substantially Equivalent on April 28, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2022
- Date Received
- January 28, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type