510(k) K091951
K091951 is an FDA 510(k) premarket notification submitted by Biomedical Ent., Inc. for the device "HAMMERLOCK". The FDA issued a decision of Substantially Equivalent on February 19, 2010. 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
- February 19, 2010
- Date Received
- July 1, 2009
- 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