510(k) K030971
- Device
- MODIFICATION TO MODULAR PLUS REVISION STEM
- Applicant
- PLUS ORTHOPEDICS
- 510(k) number
- K030971
- Product code
- LWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-24
- Date received
- 2003-03-28
- Regulation
- 888.3360
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- J.D. WEBB
- Address
- 1001 Oakwood Blvd. Round Rock TX US 78681 78681
FDA Registration Numbers#
- 3015516266
- 3008812251
- 2249697
- 3036756245
- 3008021110
- 3003541440
- 3004142400
- 9613350
- 3010120135
- 1722511
- 3009241418
- 3007740680
- 3000236920
- 9610612
- 3009959868
- 1827096
- 3008556682
- 3012916784
- 1720929
- 3002807295
- 3000196378
- 9616680
- 3010536692
- 3002806470
- 3009871135
- 3007353762
- 3013302242
- 1000547811
- 1064858
- 3003477135
- 3010173425
- 9613369
- 3021008900
- 1057425
- 3006001176
- 3006395932
- 1531174
- 3015207155
- 3006356043
- 3010123256
- 3002807314
- 3009888740
- 1828464
- 2242737
- 3002806603
- 2183744
- 3015542154
- 3013055499
- 3005323511
- 3004371426
- 3005718816
- 3006809628
- 3005061536
- 3005551626
- 1818910
- 3008544874
- 3043543260
- 3033509898
- 3001278222
- 3010206549
- 3030412764
- 2245304
- 2134470
- 3010314800
- 3003595343
- 1221053
- 1645151
- 1038671
- 1649518
- 3026771806
- 1450662
- 2133928
- 3020155054
- 1225838
- 1526534
- 3005562917
- 3007120646
- 3003761012
- 1828288
- 1218882
Source Documents#
Other 510(k) Records For Product Code LWJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | 2012-10-12 |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | 2011-03-09 |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | 2009-04-21 |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-09-09 |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | 2007-01-31 |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | 2007-01-16 |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | 2006-12-21 |
| K061699 | EXCIA | Aesculap, Inc. | 2006-08-18 |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | 2005-11-18 |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005-08-15 |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | 2005-03-16 |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | 2005-01-25 |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 2004-07-28 |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | 2003-09-23 |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | 2003-09-22 |
Legacy Summary#
summary
FDA Review#
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