| Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
|---|
| 510(k) Number |
K172054 |
|---|
| Device Name |
Materialise Glenoid Positioning System |
|---|
| Applicant |
| Materialise NV |
| Technologielaan 15 |
|
Leuven,
BE
3001
|
|
| Applicant Contact |
Oliver Clemens |
| Correspondent |
| Materialise NV |
| Technologielaan 15 |
|
Leuven,
BE
3001
|
|
| Correspondent Contact |
Oliver Clemens |
| Regulation Number | 888.3660
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/06/2017 |
|---|
| Decision Date | 11/03/2017 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Orthopedic
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|