Product code MJT
- Device name
- Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990712 | OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM | Howmedica Osteonics Corp. | 1999-07-20 |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | Endotec, Inc. | 1999-04-29 |
| K960363 | BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 | Biomet, Inc. | 1997-02-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00880304212398 | BIO-MODULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304007802 | BIO-MODULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304003958 | BIO-MODULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304002388 | BIO-MODULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304001619 | BI-ANGULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304002722 | BI-ANGULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304003477 | BI-ANGULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304212411 | BIO-MODULAR / BI-POLAR SHOULDER | Biomet Orthopedics, LLC | 2015-10-24 |
| 07613327137682 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137897 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137774 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137767 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137729 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137712 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137699 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 00814193025449 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025562 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025555 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025548 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025531 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025470 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025463 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |
| 00814193025456 | B-P TOTAL SHOULDER SYSTEM | ENDOTEC, INC. | 2015-09-17 |