Panels › Physical Medicine › Product code ISY · Class 1
Joint, Knee, External Limb Component
Regulation 890.3420
0510(k)s in 12 months (1 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in ISY
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur North America Inc | 0 | 5 |
| Ottobock Orthopedic Industrie | 0 | 3 |
| Otto Bock Healthcare GmbH | 0 | 2 |
| Otto Bock Healthcare Product | 0 | 2 |
| Bock,Otto,Orthopedic Ind,Inc | 0 | 1 |
| Medi Manufacturing Inc | 0 | 1 |
| Ossur | 0 | 1 |
| Ossur Engineering, Inc | 0 | 1 |
| Ossur H / F | 0 | 1 |
| Rizzoli Ortopedica S.P.A. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2019 | Ottobock Orthopedic Industrie 21Y15 MagValve
Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air Terminated |
ISY | None listed |
| Jan 10, 2019 | Ottobock Orthopedic Industrie 21Y14=S PushValve upper part
Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used t Terminated |
ISY | None listed |
| Jan 10, 2019 | Ottobock Orthopedic Industrie 21Y14 PushValve
Product Usage:
The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate ai Terminated |
ISY | None listed |
| Sep 12, 2017 | Otto Bock Healthcare Product OTTO BOCK Kenevo knee joints Model 3C60=ST Terminated |
ISY | None listed |
| Sep 12, 2017 | Otto Bock Healthcare Product OTTO BOCK Kenevo knee joints Model 3C60 Terminated |
ISY | None listed |
| Jan 4, 2016 | Otto Bock Healthcare GmbH Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb. Terminated |
ISY | None listed |
| Jul 24, 2015 | Otto Bock Healthcare GmbH Ottobock Pheon 3R62 Knee Joint
The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attach Terminated |
ISY | None listed |
| Feb 6, 2012 | Ossur H / F Total Knee Junior Model Number 1100
Product Usage:
The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system. Terminated |
ISY | None listed |
| Mar 25, 2011 | Ossur Engineering, Inc Ossur Total Knee, Model Number: 2100
The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads. Terminated |
ISY | None listed |
| Dec 16, 2009 | Bock,Otto,Orthopedic Ind,Inc Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany.
Pediatric Prosthetic Device used by Lower Limb amputees. Terminated |
ISY | None listed |
| Jul 12, 2007 | Ossur Ossur Total Knee Model Number 2100, external knee prosthesis. Terminated |
ISY | None listed |
| Apr 24, 2007 | Medi Manufacturing Inc Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant). Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee. Terminated |
ISY | None listed |
| May 14, 2003 | Ossur North America Inc Mauch XG, Caron Knee Frame.
Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Terminated |
ISY | None listed |
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