Product code MBL
- Device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3358
- 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 |
|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021-08-24 |
| K201701 | R3 HA Coated Acetabular Shells | Smith & Nephew, Inc. | 2020-10-06 |
| K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | 2018-11-19 |
| K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016-12-14 |
| K122382 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | 2012-10-22 |
| K113848 | R3 XLPE LINERS | Smith & Nephew, Inc. | 2012-04-27 |
| K102370 | R3 XLPE ANTEVERTED LINERS | Smith & Nephew, Inc. | 2011-01-19 |
| K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | Smith & Nephew, Inc. | 2010-01-26 |
| K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | Smith & Nephew, Inc. | 2009-11-03 |
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2007-06-06 |
| K061253 | REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2006-05-31 |
| K960094 | REFLECTION DUAL DIMENSION SHELL | Smith & Nephew Richards, Inc. | 1996-03-27 |
| K931107 | LOGYK ACETABULAR COMPONENT SYSTEM | Arthronics, Inc. | 1994-03-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613153071433 | Restoration | 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 |
| 07613153072874 | 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 |
| 07613153071440 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071273 | 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 |
| 07613153071310 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071297 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071280 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |