PAXEON RECONSTRUCTION LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (10) Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (KWZ) (3)

Premarket Exempt

Clear

Paxeon Origin - 08177570200528 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 13 Collared

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin Coxa Vara Hip Stem - 08177570200535 Catalog Number :

Device Description : Origin Stem, Coxa Vara Size 13

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH, KWZ

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200542 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 14

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200559 Catalog Number :

Device Description : Origin Stem, High Offset Size 14

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200566 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 14 Collared

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin Coxa Vara Hip Stem - 08177570200573 Catalog Number :

Device Description : Origin Stem, Coxa Vara Size 14

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH, KWZ

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200580 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 15

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200597 Catalog Number :

Device Description : Origin Stem, High Offset Size 15

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200603 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 15 Collared

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin Coxa Vara Hip Stem - 08177570200610 Catalog Number :

Device Description : Origin Stem, Coxa Vara Size 15

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH, KWZ

Prescription Use : Yes

Device Count : 1

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