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) (2)

Premarket Exempt

Clear

Paxeon Origin - 08177570200429 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 11

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200436 Catalog Number :

Device Description : Origin Stem, High Offset Size 11

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200443 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 11 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 - 08177570200450 Catalog Number :

Device Description : Origin Stem, Coxa Vara Size 11

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH, KWZ

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200467 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 12

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200474 Catalog Number :

Device Description : Origin Stem, High Offset Size 12

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200481 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 12 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 - 08177570200498 Catalog Number :

Device Description : Origin Stem, Coxa Vara Size 12

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH, KWZ

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200504 Catalog Number :

Device Description : Origin Stem, Standard Offset Size 13

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

Paxeon Origin - 08177570200511 Catalog Number :

Device Description : Origin Stem, High Offset Size 13

Device Class : 2

Duns Number: 080437990

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

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