510(k) K221346
K221346 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "Stryker VariAx 2 MIS Calcaneus". The FDA issued a decision of Substantially Equivalent on Jul 8, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker GmbH has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 2022
- Date Received
- May 9, 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
- 510(k)