510(k) K180087
K180087 is an FDA 510(k) premarket notification submitted by A.M. Surgical, Inc. for the device "A.M. Surgical Intramedullary Fixation Device". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code HTY (Pin, Fixation, Smooth), 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
- May 18, 2018
- Date Received
- January 12, 2018
- 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