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#
- 9616680
- 1218882
- 1000577893
- 3006128100
- 8010379
- 2528981
- 9610612
- 3012916784
- 3021008900
- 3004986960
- 3007740680
- 3002807314
- 1226188
- 9615674
- 3010287737
- 3005323511
- 3033509898
- 3009760038
- 3005562917
- 2648920
- 3010206549
- 3002907620
- 3000196378
- 3026771806
- 3009973505
- 1043653
- 3004371426
- 1221053
- 2249697
- 3008868758
- 1644408
- 3006395932
- 2245304
- 3002807090
- 3010097171
- 1064858
- 3010363503
- 3008556682
- 9616671
- 8043792
- 1057425
- 1818910
- 1000547811
- 1836357
- 3020282716
- 1220477
- 3005061536
- 3009888740
- 3003761012
- 3006001176
- 3008021110
- 9616944
- 3005551626
- 1020279
- 3003541440
- 1825034
- 3002806470
- 1226544
- 3001278222
- 3009241418
- 1649518
- 1833986
- 3013055499
- 1828288
- 1822565
- 3016438694
- 3023852420
- 3010536692
- 3002806535
- 1526534
- 3006809628
- 3025603301
- 9613350
- 1219655
- 3002807315
- 3009546990
- 3009732568
- 3012392319
- 3020155054
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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