510(k) K131640
K131640 is an FDA 510(k) premarket notification submitted by Biomedical Ent., Inc. for the device "SMOOTH OR THREADED METALLIC BONE FASTENER". The FDA issued a decision of Substantially Equivalent on October 16, 2013. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Biomedical Ent., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2013
- Date Received
- June 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type