510(k) K062980
K062980 is an FDA 510(k) premarket notification submitted by Bioretec, Ltd. for the device "ACTIVASCREW". The FDA issued a decision of Substantially Equivalent on November 22, 2006. 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 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2006
- Date Received
- September 29, 2006
- 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