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OSSUR

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22424742242474OSSUR AMERICAS1Y2026-01-01680 Grove Rd West Deptford NJ US 08086
30037646103003764610Ossur Iceland ehf.1N2026-01-01GRJOTHALS 5 REYKJAVIK IS 110
30041619503004161950OSSUR EUROPE B.V.1N2026-01-01De Schakel 70 Eindhoven Noord-Brabant NL 5651 GH
30083955453008395545OSSUR1N2026-01-01606 Broadway Newburgh NY US 12550
30104053733010405373Ossur Orlando1N2026-01-019545 S John Young Pkwy, Suite 100 Orlando FL US 32819
18362483002440200OSSUR AMERICAS1N2020-04-25910 BURSTEIN DR. ALBION MI US 49224
20854461000519909Ossur Americas1N2020-04-2527051 Towne Centre Drive Suite 100 Foothill Ranch CA US 92610
30062210313006221031Ossur Bayreuth1N2020-04-25Logistigpark 7 a Bayreuth Bayern DE 95448

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165361558668378K930021J TONGSHAX1995-12-06
165381558668378K930021J TONGSHAX1995-12-06
165361561219794K864969JMS HALO APPLICATION TRAYKDD1987-02-18
165381561219794K864969JMS HALO APPLICATION TRAYKDD1987-02-18
1139551561219794K864969JMS HALO APPLICATION TRAYKDD1987-02-18
165361260017987K844490TRACTION ACCESSORIESILZ1985-02-21
165381260017987K844490TRACTION ACCESSORIESILZ1985-02-21
1139551260017987K844490TRACTION ACCESSORIESILZ1985-02-21
165361401284868K822780CERVICAL BRACEJEC1982-10-06
165381401284868K822780CERVICAL BRACEJEC1982-10-06
1139551401284868K822780CERVICAL BRACEJEC1982-10-06
165361917323338K051918RESOLVE OPEN BACK HALO RINGSHAX2005-08-17
165381917323338K051918RESOLVE OPEN BACK HALO RINGSHAX2005-08-17
1139551917323338K051918RESOLVE OPEN BACK HALO RINGSHAX2005-08-17
165362046221130K040363CERAMIC TIPPED SKULL PINLYT2004-04-12
165382046221130K040363CERAMIC TIPPED SKULL PINLYT2004-04-12
1139552046221130K040363CERAMIC TIPPED SKULL PINLYT2004-04-12
165362031579289K023959JEROME GLASS RINGHAX2003-02-21
165382031579289K023959JEROME GLASS RINGHAX2003-02-21
1139552031579289K023959JEROME GLASS RINGHAX2003-02-21
1139551008221882
165361015936965
1139551015936965
165361030140808
1139551030140808
165361115997132
1139551115997132
165361140686662
1139551140686662
2086101179090215
165361220118736
1139551220118736
1139551246251370
1139551246847777
165361268981946
1139551268981946
165381342107665
1139551342107665
2086101342107665
165361354749776
1139551354749776
165361364540404
1139551364540404
165301373962216
165361373962216
165361388062455
1139551388062455
1139551424344166
1139551472472641
1139551477262984
1139551507152415
1139551526983175
2086101526983175
165361561528353
1139551561528353
165361575387490
1139551575387490
165381620601711
1139551620601711
2086101620601711
1139551633741086
165361644361329
1139551644361329
165361649233520
1139551649233520
165361663921025
1139551663921025
165361702597471
1139551702597471
165361718388448
1139551718388448
165361741873249
1139551741873249
165301757619375
165361757619375
165381757619375
1139551757619375
1139551765769952
165361772330727
1139551772330727
1139551806317172
1139551858592068
165361902017555
1139551902017555
1139551974737900
165362024615956
165382024615956
1139552024615956
165301008221882
165361008221882
971721008221882
165301030140808
165301115997132
165301179090215
165361179090215
971721179090215
2067431179090215
165301220118736
971721220118736
165301246251370
165361246251370
971721246251370
165301246847777
165361246847777
971721246847777
165301268981946
971721268981946
165301342107665
165361342107665
971721342107665
1870861342107665
165301354749776
165301388062455
165301424344166
165361424344166
971721424344166
165301472472641
165361472472641
971721472472641
165301477262984

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAX82005-08-17
LYT32004-04-12
KDD31987-02-18
ILZ31985-02-21
JEC31982-10-06

PMN#

GUDID#

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