The following data is part of a premarket notification filed by Shoulder Innovations, Llc with the FDA for Total Shoulder System.
Device ID | K111596 |
510k Number | K111596 |
Device Name: | TOTAL SHOULDER SYSTEM |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | SHOULDER INNOVATIONS, LLC 4670 FULTON STREET E Ada, MI 49301 |
Contact | Andrew Rodenhouse |
Correspondent | Andrew Rodenhouse SHOULDER INNOVATIONS, LLC 4670 FULTON STREET E Ada, MI 49301 |
Product Code | KWS |
Subsequent Product Code | HSD |
Subsequent Product Code | KWT |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-08 |
Decision Date | 2011-07-05 |
Summary: | summary |