TORNIER, INC.

TORNIER, INC.

Address:10801 Nesbitt Avenue South,Bloomington,MN,55437,US

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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, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained (PKC) (2)

Premarket Exempt

No Yes

Clear

Tornier Perform - 00846832092192 Catalog Number : DWM003A

Device Description : US Anatomic Nucleus

Device Class : 2

Duns Number: 968990812

Premarket Exempt : No

Product Code : PKC

Prescription Use : Yes

Device Count : 1

Tornier Perform - 00846832092208 Catalog Number : DWM004A

Device Description : US Anatomic Nucleus

Device Class : 2

Duns Number: 968990812

Premarket Exempt : No

Product Code : PKC

Prescription Use : Yes

Device Count : 1

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