510(k) K140130
- Device
- X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
- Applicant
- ENCORE MEDICAL, L.P.
- 510(k) number
- K140130
- Product code
- OQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-06
- Date received
- 2014-01-17
- Regulation
- 888.3358
- Classification name
- Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, 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
- TEFFANY HUTTO
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3010375065
- 3004748528
- 1526711
- 1834379
- 3030412764
- 3003761012
- 3003541440
- 2648920
- 3005562917
- 3003477135
- 1020279
- 3007420745
- 1226544
- 3002806535
- 3009959868
- 8044172
- 2030624
- 3013413393
- 3009106092
- 1531174
- 3000264985
- 3006809628
- 1530390
- 3011189525
- 1822565
- 3014302784
- 3014833750
- 3020155054
- 2183744
- 3010057495
- 1529009
- 8043792
- 3004142400
- 9614209
- 2032521
- 3012725451
- 1450662
- 1221763
- 3015398319
- 3006801265
- 3004153240
- 3010097171
- 3013176080
- 3002807315
- 3002807310
- 3002807090
- 3004153896
- 3010041993
- 1057425
- 1424263
- 3043543260
- 3010386387
- 9611390
- 3010178296
- 1720929
- 1644408
- 3010531069
- 3033509898
- 3002806603
- 1828464
- 1833506
- 3010047454
- 3008744062
- 3005360851
- 3007923096
- 3014763043
- 3008544874
- 1825034
- 1649518
- 9681465
- 1835251
- 3004188066
- 3001278222
- 3010120135
- 3012319330
- 3035366890
- 3008021110
- 8010916
- 2246552
Source Documents#
Other 510(k) Records For Product Code OQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | 2021-08-20 |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | 2021-04-02 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | 2020-07-16 |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | 2020-03-11 |
| K172651 | FMP Extended Liners | Encore Medical L.P. | 2017-12-13 |
| K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies | 2017-11-16 |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | Total Joint Orthopedics, Inc. | 2017-10-27 |
| K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, Inc. | 2015-05-11 |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Total Joint Orthopedics, Inc. | 2014-10-09 |
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG | Novosource, Inc. | 2014-06-27 |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | Consensus Orthopedics, Inc. | 2013-12-17 |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | Aesculap Implant System, Inc. | 2013-10-30 |
| K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | Encore Medical L.P. | 2013-09-23 |
| K122158 | PBP TOTAL HIP SYSTEM | Pipeline Biomedical Products, LLC | 2012-12-11 |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | Stelkast Company | 2012-10-09 |
Legacy Summary#
summary
FDA Review#
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