Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008395545

FEI Number

3008395545

Entity Name

OSSUR

City/State/Country

Newburgh, NY, US

Establishment Address

606 Broadway, Newburgh, NY 12550, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSUR Americas (Owner Number: 9026971)

Owner / Operator Contact Address

200 Spectrum Center Drive, Suite 700, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Livingskin Partial finger Livingskin Toe Livingskin Full hand Livingskin Finger band Livingskin Below elbow Livingskin Partial hand Livingskin Foot Livingskin Full finger Livingskin Above Elbow Livingskin PIPDriver® MCPDriver® ThumbDriver® GripLock Finger® Thigh Sleeve Relax Night Care Stump Shrinker i-limb skin natural Comfort SCS i-limb skin match Volume Compensation Sock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2004-01-07
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2016-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSSUR Americas

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008523132	Ossur Mexico	Tijuana Baja California, MX
3010405373	Ossur Orlando	Orlando, FL, US
3003764610	Ossur Iceland ehf.	REYKJAVIK, IS
3004161950	OSSUR EUROPE B.V.	Eindhoven Noord-Brabant, NL
3006532285	Touch Bionics Ltd	Livingston West Lothian, GB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008395545. Last updated year: 2026. Please use registration number 3008395545 when referencing this establishment in official correspondence.