510(k) K063769
K063769 is an FDA 510(k) premarket notification submitted by Alpha-Bio Tec , Ltd. for the device "ALPHA BIO BONE FIXATION SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 30, 2007. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Alpha-Bio Tec , Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2007
- Date Received
- Dec 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type
- 510(k)