510(k) K151264 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Restoration Anatomic Shell
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 10, 2015 |
| Received | May 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17) Terminated |
LPH | None listed |
| May 7, 2020 | Howmedica Osteonics Corp. Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17) Terminated |
LPH | None listed |
| Jun 3, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile
Catalog Numbers 2199-2022, 2199-2028 and 2199-2032.
For use in total hip arthroplasty. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.