510(k) K261057
K261057 is an FDA 510(k) premarket notification submitted by Bioretec, Ltd. for the device "ActivaScrew Cannulated COM". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Bioretec, Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2026
- Date Received
- March 31, 2026
- 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