ClearanceBrief
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)
Get daily alerts for ISHSample briefCSV

Top companies in ISH

Company510(k)sRecalls
Ossur02
Ossur Americas02
Ossur H / F02
Ossur North America Inc02
Applied Composite Technology01
Bock,Otto,Orthopedic Ind,Inc01
College Park Industries, Inc.01
Kiswood Manufacturing, Inc.10
Mauch Laboratories, Inc.10
Noble Fiber Technologies, Inc.10
DateFirm and productCodeLinked 510(k)
Jun 13, 2023Ossur 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
ISHNone listed
May 30, 2022Ossur Americas
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Terminated
ISHNone listed
Nov 4, 2015Otto 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
ISHNone listed
Mar 17, 2015Ossur 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
ISHNone listed
Feb 6, 2014Ossur 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
ISHNone listed
Nov 19, 2013Ossur 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
ISHNone listed
May 23, 2012College 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
ISHNone listed
Aug 7, 2007Applied 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
ISHNone listed
Jan 10, 2007Ossur
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
ISHNone listed
Jan 10, 2007Southern Prosthetic Supply Co.
SPS Blue Line Tube Clamp Adapters, Product No. BL120M
Terminated
ISHNone listed
Jan 12, 2006Ossur
Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.
Terminated
ISHNone listed
Aug 18, 2004Bock,Otto,Orthopedic Ind,Inc
Modular Knee Joint with Friction Brake
Terminated
ISHNone listed
Jul 20, 2004Ossur North America Inc
VSP Shock Module (as part of a prosthetic foot).
Terminated
ISHNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.