510(k) K022556
- Device
- REFLECTION MODIFIED ACETABULAR SHELLS
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K022556
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-28
- Date received
- 2002-08-02
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIM KELLY
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3014315560
- 3015516266
- 3008812251
- 3020282716
- 2249697
- 3036756245
- 3008021110
- 3003541440
- 1000517406
- 1834379
- 3004142400
- 1835444
- 3010041993
- 9613350
- 3013086329
- 3010120135
- 1722511
- 3009241418
- 3007740680
- 3000236920
- 9610612
- 3009959868
- 3012319330
- 1827096
- 3008556682
- 3008572101
- 3009813841
- 1720929
- 3014763043
- 1643817
- 9681465
- 3009106092
- 3000196378
- 9616680
- 3010536692
- 3007539489
- 3009998573
- 3002806470
- 3009871135
- 3007353762
- 1000550978
- 3010375065
- 3013302242
- 1000547811
- 3021386586
- 1064858
- 1530390
- 3003477135
- 3010173425
- 9613369
- 3010041693
- 3021008900
- 3022142628
- 2032521
- 1057425
- 3010846112
- 3002807112
- 3006395932
- 1531174
- 3015207155
- 3002807408
- 3010047454
- 3006356043
- 3010123256
- 3020162561
- 3002807314
- 1225675
- 3009888740
- 3009173317
- 3003061090
- 1828464
- 2242737
- 3006946279
- 3002806603
- 3026776
- 3013055499
- 2183744
- 2531477
- 3005323511
- 3015542154
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | 2026-06-05 |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
Legacy Summary#
summary
FDA Review#
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