Product code JDJ
- Device name
- Mesh, Surgical, Acetabular, Hip, Prosthesis
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- 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 |
|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Link America, Inc. | 1997-10-22 |
| K970957 | OSTEONICS RESTORATION ACETABULAR RING | Osteonics Corp. | 1997-06-03 |
| K963940 | EXETER MESH | Howmedica, Inc. | 1997-02-13 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Smith & Nephew Richards, Inc. | 1996-09-17 |
| K962007 | PROTRUSION CAGES | Depuy, Inc. | 1996-08-01 |
| K925883 | OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS | Osteonics Corp. | 1993-06-15 |
| K890450 | INTERMEDICS APR(TM) II FEMORAL COMPONENT | Intermedics Orthopedics | 1989-08-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810038631110 | Easy@Home Multi-Drug Test Cup (5 tests kit) | EASY HEALTHCARE CORPORATION | 2020-06-26 |
| 00850253007536 | Easy@Home Multi-Drug Test Cup (5 tests kit) | EASY HEALTHCARE CORPORATION | 2016-09-15 |
| 00850253007543 | Easy@Home Multi-Drug Test Cup (25 tests kit) | EASY HEALTHCARE CORPORATION | 2016-09-15 |
| 00889024179707 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179363 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179387 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179639 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179646 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179660 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179677 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179684 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179691 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179332 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179714 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179721 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179738 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179745 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179349 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179325 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179318 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179301 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179295 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179271 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179264 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179257 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179240 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179233 | NA | Zimmer, Inc. | 2016-07-19 |
| 00889024179226 | NA | Zimmer, Inc. | 2016-07-19 |
| 07613327017663 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327017687 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |