510(k) K061206
K061206 is an FDA 510(k) premarket notification submitted by Acute Innovations, LLC for the device "ACUTE BONE SCREW". The FDA issued a decision of Substantially Equivalent on June 19, 2006. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Acute Innovations, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2006
- Date Received
- May 1, 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