510(k) K010051
K010051 is an FDA 510(k) premarket notification submitted by Xiros Plc for the device "POLY-TAPES WITH THE FASTLOK FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on July 13, 2001. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Xiros Plc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2001
- Date Received
- January 8, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type