510(k) clearance
ActivaScrew™ Cannulated COM
- 510(k) number
- K261057
- Applicant
- Bioretec, Ltd.
- Decision date
- Sep 4, 2026
- Date received
- Mar 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HWC
- Device type
- Screw, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Tampere, FI