FDA.report

510(k) K163585

Device
Responsive Orthopedics Total Hip Arthroplasty System
Applicant
Responsive Orthopedics, LLC
510(k) number
K163585
Product code
LZO  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-02
Date received
2016-12-20
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kathy Remsen
Address
5865 E. State Rd. 14 Columbia City IN US 46725 46725

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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