510(k) K150188
K150188 is an FDA 510(k) premarket notification submitted by Summit Medventures for the device "SMV Scientific 4.5 mm Bone Screws". The FDA issued a decision of Substantially Equivalent on April 29, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Summit Medventures has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2015
- Date Received
- January 27, 2015
- 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