510(k) K210268
K210268 is an FDA 510(k) premarket notification submitted by Azurmeds, Inc. for the device "LTJ Screws and Washer". The FDA issued a decision of Substantially Equivalent on Feb 26, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Azurmeds, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 2021
- Date Received
- Feb 1, 2021
- 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)