510(k) K162507
K162507 is an FDA 510(k) premarket notification submitted by Truemed Group, LLC for the device "Arzzt 3.5 / 4.5 Small & Large Fragments System". The FDA issued a decision of Substantially Equivalent on Aug 3, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Truemed Group, LLC has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2017
- Date Received
- Sep 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)