Product code LZY
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3360
- 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 |
|---|---|---|---|
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023-07-19 |
| K111145 | ENDO HEAD | Medacta International | 2011-08-16 |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Implantology Corp. | 1993-06-29 |
| K915548 | IONGUARD TITANIUM MODULAR HEADS | Biomet, Inc. | 1992-03-10 |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Depuy, Inc. | 1990-10-03 |
| K896580 | UNI-POLAR HEAD | Richards Medical Co., Inc. | 1990-02-15 |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Protek, Inc. | 1989-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630030804458 | AMIStem-H Proximal Coating | Medacta International SA | 2021-10-22 |
| 07630030804359 | AMIStem-H Proximal Coating | Medacta International SA | 2021-10-22 |
| 07630030804342 | AMIStem-H Proximal Coating | Medacta International SA | 2021-10-22 |
| 07630030803147 | MiniMAX Stems | Medacta International SA | 2017-08-22 |
| 07630030803154 | MiniMAX Stems | Medacta International SA | 2017-08-22 |
| 07630030803307 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803130 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803161 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803178 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803291 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803284 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803277 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803260 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803246 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803185 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803192 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803208 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803215 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803222 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803239 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030803253 | MiniMAX Stems | Medacta International SA | 2017-08-21 |
| 07630030804366 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804373 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804380 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804397 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804403 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804410 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804427 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804434 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |
| 07630030804441 | AMIStem-H Proximal Coating Femoral Stems | Medacta International SA | 2017-04-05 |