510(k) K081293 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
UNIVATION UNICONDYLAR KNEE SYSTEM
| Applicant | Aesculap Implant Systems, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Sep 22, 2008 |
| Received | May 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;
NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM;
NL472 UNIVATION F MENISCAL COMP.T3 RM Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM;
NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM;
NL478 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM;
NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM;
NL484 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM;
NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM;
NL490 UNIVATION F MENISCAL COMP.T3 R Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM;
NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM;
NL496 UNIVATION F MENISCAL COMP.T3 Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM;
NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM;
NO158Z AS UNIVATION XF TIBIA CEMENTED Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM;
NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM;
NO182Z AS UNIVATION XF FEMUR CEMENTED Terminated |
HRY | None listed |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System Tray Sysem knee implant devices as follows:
Tray Number/Set Name/Set Number
NM1090R Navigation Set ST0560;
NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.