Product code MAY
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3353
- 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 |
|---|---|---|---|
| K123604 | ABG III MONOLITHIC HIP STEM | Howmedica Osteonics Corp. | 2013-08-16 |
| K110807 | ABG II MONOLITHIC HIP STEM | Stryker Corp. | 2011-05-25 |
| K090103 | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL | Biomet, Inc. | 2009-02-11 |
| K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613153071440 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072928 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072911 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072904 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072898 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072881 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072867 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071655 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071648 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071631 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071617 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071600 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071594 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071587 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071518 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071273 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071433 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071426 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071419 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071402 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071396 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071389 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071372 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071365 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071358 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071341 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071334 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071327 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071297 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071280 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |