510(k) K161587
K161587 is an FDA 510(k) premarket notification submitted by Austin & Associates, Inc./Telos Medical Equipment for the device "Memodyn Staple". The FDA issued a decision of Substantially Equivalent on Feb 1, 2017. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2017
- Date Received
- Jun 8, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)