Device |
shoulder arthroplasty implantation system |
Regulation Description |
Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
Definition |
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. |
Physical State |
A device accessory or set of device accessories |
Technical Method |
Aids the surgeon in performing the implantation of the shoulder implant |
Target Area |
Shoulder |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | QHE |
Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
510(k)
|
Regulation Number |
888.3660
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |