510(k) K071059
- Device
- DEPUY SPA POROUS COATED PROXIMAL SLEEVE
- Applicant
- DEPUY ORTHOPAEDICS, INC.
- 510(k) number
- K071059
- Product code
- KWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-09
- Date received
- 2007-04-16
- 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
- KATHY HARRIS
- Address
- P.O. Box 988 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1834331
- 3005360851
- 1221053
- 3010009693
- 1526534
- 3017397663
- 3004513872
- 2242737
- 3016438694
- 2245304
- 3002807315
- 3009546990
- 2528981
- 3014763043
- 8010379
- 1828464
- 3003998208
- 3006395932
- 3000196378
- 3005323511
- 9613350
- 1822565
- 3004641308
- 3004153896
- 3010041693
- 3008110533
- 3006801265
- 3013176080
- 3015516266
- 3006946276
- 3011683674
- 3003595343
- 8044172
- 1835251
- 3002806535
- 3021386586
- 1827096
- 3007366790
- 3012319330
- 2249697
- 1721676
- 3009241418
- 1649518
- 3008556682
- 1424263
- 3010386387
- 3001278222
- 3026771806
- 3004635447
- 1643264
- 9610726
- 8010916
- 9616680
- 3005061536
- 2134285
- 1818910
- 3010220595
- 3010206549
- 3038503932
- 3036756245
- 1834379
- 3007913880
- 3002806470
- 3008812251
- 2648920
- 9614841
- 3011461101
- 3010287737
- 3008668801
- 1835831
- 3007120646
- 3013014058
- 3005180920
- 1220477
- 9616944
- 3006128100
- 3011277306
- 3002807310
- 3009888740
- 2246552
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 |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | 2009-03-03 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 |
| 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 |
| K063445 | PCA 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases