510(k) K132158
- Device
- NOVOHIP TOTAL HIP SYSTEM
- Applicant
- NOVOSOURCE INC
- 510(k) number
- K132158
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-02-21
- Date received
- 2013-07-12
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHARON KVISTAD
- Address
- 714 E. Monument Ave. Suite 219 Dayton OH US 45402 45402
FDA Registration Numbers#
- 1000517406
- 3010065126
- 3018052045
- 3002808022
- 3021386586
- 3031800723
- 3016778562
- 3009241418
- 3009173317
- 3002807408
- 3010041693
- 3009546990
- 1000550978
- 3002807112
- 3012319330
- 1057425
- 3015398319
- 3010047454
- 3008281151
- 3006946279
- 3015542154
- 3006085220
- 3013176080
- 9681642
- 3010531069
- 1835572
- 3017397663
- 2134470
- 9616680
- 1827096
- 3036756245
- 1226544
- 3004142400
- 9613369
- 3012119238
- 3010363503
- 2245304
- 1835251
- 1834331
- 1834379
- 3007353762
- 3043543260
- 3004638532
- 1061927
- 3010388970
- 1220477
- 3008544874
- 3012275107
- 1221053
- 3006395932
- 3026771806
- 2528981
- 2648920
- 3006946276
- 9616671
- 9617840
- 3012392319
- 1225675
- 3010536692
- 3012130008
- 3010386387
- 3004513872
- 1054811
- 3010576282
- 3011170410
- 3001278222
- 1020279
- 3010039400
- 1835444
- 3014315560
- 3006809628
- 3007913880
- 3006017180
- 3005718816
- 3008262872
- 3010057495
- 1000547811
- 3010288357
- 3002498892
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026-08-28 |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 |
| 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 |
Legacy Summary#
summary
FDA Review#
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