510(k) K203523
K203523 is an FDA 510(k) premarket notification submitted by Aju Pharm Co., Ltd. for the device "Fixone hybrid knotless anchor". The FDA issued a decision of Substantially Equivalent on December 25, 2021. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Aju Pharm Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 25, 2021
- Date Received
- December 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type