510(k) K180544
K180544 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Static Staples". The FDA issued a decision of Substantially Equivalent on July 24, 2018. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2018
- Date Received
- March 1, 2018
- Clearance Type
- Traditional
- 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