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#
- 3004153240
- 1038671
- 3007189546
- 3007353762
- 3006085220
- 3011189525
- 3005751028
- 3001278222
- 1649518
- 3003998208
- 3026776
- 3015978338
- 2249615
- 3010388970
- 3040391045
- 3013791180
- 3012319330
- 3008572101
- 3048626106
- 3009546990
- 3014302784
- 1644408
- 9616671
- 1226544
- 3010536692
- 1722511
- 3002807090
- 3013014058
- 3004641308
- 2245304
- 3008544874
- 3004635447
- 3002806470
- 3025603301
- 3033509898
- 3004748528
- 3009959868
- 3007311878
- 1828288
- 3014833750
- 1000550978
- 3008668801
- 3012329926
- 1836357
- 3005360851
- 2134285
- 1721676
- 3005061536
- 1526534
- 1833920
- 3012755988
- 2032521
- 3010097171
- 3013450937
- 2183744
- 3006128100
- 3007913880
- 9611390
- 3011277306
- 3009882462
- 3004638532
- 9681642
- 3005581234
- 3010120135
- 3009173317
- 3012119238
- 3006017180
- 1833986
- 3010041693
- 2648920
- 3009973505
- 3002498892
- 3009760038
- 3008395353
- 8010916
- 3009998573
- 3008021110
- 3009973336
- 3009813841
- 3006946276
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261453 | G7® Acetabular System | Zimmer Biomet | 2026-09-23 |
| 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 |
Legacy Summary#
summary
FDA Review#
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