510(k) K180932
K180932 is an FDA 510(k) premarket notification submitted by Diamond Orthopedic, LLC for the device "Diamond Orthopedic Bone Fixation Screws and Pins". The FDA issued a decision of Substantially Equivalent on May 9, 2018. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2018
- Date Received
- Apr 10, 2018
- Clearance Type
- Special
- 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
- 510(k)