510(k) K220359
K220359 is an FDA 510(k) premarket notification submitted by Microware Precision Co., Ltd. for the device "Tandry Compression Screw System". The FDA issued a decision of Substantially Equivalent on September 20, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Microware Precision Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2022
- Date Received
- February 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type