510(k) K083566
- Device
- R3 CONSTRAINED LINER, CONSTRAINED LINER
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K083566
- Product code
- KWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-03
- Date received
- 2008-12-03
- Regulation
- 888.3310
- Classification name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON SELLS
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 2245304
- 3004748528
- 3009173317
- 3005913274
- 1834379
- 3016438694
- 2648920
- 3003595343
- 3011295718
- 1020279
- 3008868758
- 3009888740
- 3005551626
- 3002806535
- 8044172
- 3011274144
- 1531174
- 3000264985
- 3004641308
- 3010220595
- 3010163695
- 3010039400
- 3010206549
- 3006809628
- 3017397663
- 3009973336
- 3027484613
- 1822565
- 3014302784
- 3000236920
- 3007200272
- 3010057495
- 2249615
- 1529009
- 8043792
- 3012725451
- 3000196378
- 3008102042
- 1450662
- 1221763
- 3006128100
- 9613369
- 3010314800
- 3006801265
- 1833986
- 3021008900
- 3013176080
- 3002807315
- 3002807310
- 3022142628
- 3002907620
- 2531477
- 3004153896
- 3010537287
- 1424263
- 1018470
- 3014252644
- 3010386387
- 3015516266
- 1219655
- 3009871135
- 1043653
- 3026771806
- 3010178296
- 3003998208
- 3007913880
- 3003387384
- 1644408
- 3009546990
- 3013014058
- 3033509898
- 3006946276
- 3002806603
- 1835831
- 1828464
- 3006946279
- 3011277306
- 3008744062
- 3004513872
Source Documents#
Other 510(k) Records For Product Code KWZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025-07-31 |
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | 2024-04-04 |
| K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017-06-19 |
| K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | Encore Medical L.P. | 2017-03-02 |
| K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016-11-09 |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | 2012-10-16 |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011-09-09 |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | 2010-12-03 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | 2007-11-09 |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | 2007-07-19 |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | 2007-07-13 |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2007-05-18 |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
Legacy Summary#
summary
FDA Review#
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