510(k) K083566 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
R3 CONSTRAINED LINER, CONSTRAINED LINER
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 3, 2009 |
| Received | Dec 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | None listed |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | None listed |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | None listed |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO,
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repl Terminated |
KWZ | None listed |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.