510(k) K191344
K191344 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module". The FDA issued a decision of Substantially Equivalent on Oct 3, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has 352 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 3, 2019
- Date Received
- May 20, 2019
- 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)