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 |
|---|---|---|---|
| 04546540273260 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327040135 | Tritanium | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327040128 | Tritanium | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327040111 | Tritanium | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327040098 | Tritanium | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540432001 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402189 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402172 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402165 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402158 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273390 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273369 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273345 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273314 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273291 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012804 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012972 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012965 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012958 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012941 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012903 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012897 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012880 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012873 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012866 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012859 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012842 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012835 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012828 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327012811 | V40 Head | Howmedica Osteonics Corp. | 2015-09-24 |