510(k) K896048 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
S-ROM/NOILES MARK 3
| Applicant | Joint Medical Products Corp., Stamford CT, US |
| Decision | Substantially Equivalent, Mar 14, 1990 |
| Received | Oct 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623401 L
S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there i Terminated |
KRO | None listed |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there Terminated |
KRO | None listed |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there i Terminated |
KRO | None listed |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there i Terminated |
KRO | None listed |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there Terminated |
JWH | None listed |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.