510(k) K193497
K193497 is an FDA 510(k) premarket notification submitted by Aju Pharm Co., Ltd. for the device "Fixone Biocomposite Interference Screw". The FDA issued a decision of Substantially Equivalent on January 5, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Aju Pharm Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2021
- Date Received
- December 17, 2019
- 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