510(k) K163585
K163585 is an FDA 510(k) premarket notification submitted by Responsive Orthopedics, LLC for the device "Responsive Orthopedics Total Hip Arthroplasty System". The FDA issued a decision of Substantially Equivalent on Jun 2, 2017. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Responsive Orthopedics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2017
- Date Received
- Dec 20, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)