510(k) K191771
K191771 is an FDA 510(k) premarket notification submitted by A.M. Surgical, Inc. for the device "SECURE Screw". The FDA issued a decision of Substantially Equivalent on October 16, 2019. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. A.M. Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2019
- Date Received
- July 2, 2019
- 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