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Company

Ossur

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)

6recalls (0 in 12 months)

3recalls that name a 510(k)

Product codes

Code	Device	Records
LYT	Fixation Accessory	3
ISH	Component, External, Limb, Ankle/Foot	2
ISY	Joint, Knee, External Limb Component	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
No clearances in this window.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 2, 2009	Ossur Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS Terminated	LYT	K023959 K040363
Jan 2, 2009	Ossur Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS Terminated	LYT	K023959 K040363
Jan 2, 2009	Ossur Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S Terminated	LYT	K023959 K040363
Jul 12, 2007	Ossur Ossur Total Knee Model Number 2100, external knee prosthesis. Terminated	ISY	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 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

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