510(k) K230874
K230874 is an FDA 510(k) premarket notification submitted by Suzhou Endophix Co., Ltd. for the device "Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath". The FDA issued a decision of Substantially Equivalent on May 23, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Suzhou Endophix Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2023
- Date Received
- March 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type