510(k) K072888
- Device
- REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
- Applicant
- ENCORE MEDICAL, L.P.
- 510(k) number
- K072888
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-01-10
- Date received
- 2007-10-10
- 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
- TIFFANY HUTTO
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 1225675
- 3010375065
- 2245304
- 9616671
- 3004748528
- 3009173317
- 1526711
- 3010132111
- 3005913274
- 1834379
- 3016438694
- 3030412764
- 3003761012
- 3003541440
- 2648920
- 3003595343
- 3005562917
- 3011295718
- 3003477135
- 1020279
- 3011170410
- 3008868758
- 3007420745
- 3009888740
- 3005551626
- 3005751028
- 3006536454
- 3011015572
- 1000550978
- 1226544
- 3002806535
- 3009959868
- 1054811
- 3014315560
- 3011274144
- 8044172
- 3013413393
- 2030624
- 3009106092
- 1531174
- 3000264985
- 3004641308
- 3002807408
- 1064858
- 3010123256
- 3010220595
- 3010039400
- 3010163695
- 1000517406
- 3011189525
- 3009973336
- 3006809628
- 3017397663
- 3014302784
- 3014833750
- 3027484613
- 3036773273
- 1722511
- 1822565
- 3000236920
- 3020155054
- 2183744
- 3010057495
- 3007200272
- 2249615
- 1529009
- 8043792
- 3004142400
- 9614209
- 2032521
- 3012725451
- 1000547811
- 9681642
- 3000196378
- 3012329926
- 1450662
- 3006128100
- 1221763
- 3015398319
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 |
Legacy Summary#
summary
FDA Review#
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