Panels › Physical Medicine › Product code ISH · Class 1
Component, External, Limb, Ankle/Foot
Regulation 890.3420
0510(k)s in 12 months (4 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in ISH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur | 0 | 2 |
| Ossur Americas | 0 | 2 |
| Ossur H / F | 0 | 2 |
| Ossur North America Inc | 0 | 2 |
| Applied Composite Technology | 0 | 1 |
| Bock,Otto,Orthopedic Ind,Inc | 0 | 1 |
| College Park Industries, Inc. | 0 | 1 |
| Kiswood Manufacturing, Inc. | 1 | 0 |
| Mauch Laboratories, Inc. | 1 | 0 |
| Noble Fiber Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2023 | Ossur H / F Icelock 125 Ratchet, REF: L-125000;
Icelock 600XM Ratchet, REF: L-621200;
Icelock 621 Ratchet, REF: L-621000;
Icelock 621 Ratchet Adaption Kit, REF: L-621100;
Ratchet Lock Body, REF: L-692020 Open, Classified |
ISH | None listed |
| May 30, 2022 | Ossur Americas OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. Terminated |
ISH | None listed |
| Nov 4, 2015 | Otto Bock Healthcare GmbH iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot. Terminated |
ISH | None listed |
| Mar 17, 2015 | Ossur H / F LP Rotate Foot System prosthetic device for fitting lower extremity amputations.
-Low profile foot module with adjustable shock absorber and rotation
with progressive stiffening
-Build height: with Terminated |
ISH | None listed |
| Feb 6, 2014 | Ossur Americas, Inc. The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees.
The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products Terminated |
ISH | None listed |
| Nov 19, 2013 | Ossur North America Inc Fixed Offset Adapter, A-642100.
The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy Terminated |
ISH | None listed |
| May 23, 2012 | College Park Industries, Inc. Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs. Terminated |
ISH | None listed |
| Aug 7, 2007 | Applied Composite Technology VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT. Terminated |
ISH | None listed |
| Jan 10, 2007 | Ossur Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007 Terminated |
ISH | None listed |
| Jan 10, 2007 | Southern Prosthetic Supply Co. SPS Blue Line Tube Clamp Adapters, Product No. BL120M Terminated |
ISH | None listed |
| Jan 12, 2006 | Ossur Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR. Terminated |
ISH | None listed |
| Aug 18, 2004 | Bock,Otto,Orthopedic Ind,Inc Modular Knee Joint with Friction Brake Terminated |
ISH | None listed |
| Jul 20, 2004 | Ossur North America Inc VSP Shock Module (as part of a prosthetic foot). Terminated |
ISH | None listed |
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