510(k) K191053
K191053 is an FDA 510(k) premarket notification submitted by Xiros, Ltd. for the device "Xtreme-Loop". The FDA issued a decision of Substantially Equivalent on July 17, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Xiros, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2019
- Date Received
- April 19, 2019
- 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