Metalogix

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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

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (KTT) (10)

Premarket Exempt

Clear

Revolution External Plating System - 00854641008303 Catalog Number :

Device Description : Self Drill Half-Pin 6x70x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008310 Catalog Number :

Device Description : Self Drill Half-Pin 6x80x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008327 Catalog Number :

Device Description : Blunt Half-Pin 6x40x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008334 Catalog Number :

Device Description : Blunt Half-Pin 6x50x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008341 Catalog Number :

Device Description : Blunt Half-Pin 6x60x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008358 Catalog Number :

Device Description : Blunt Half-Pin 6x70x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008365 Catalog Number :

Device Description : Blunt Half-Pin 6x80x215mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008372 Catalog Number :

Device Description : Steinmann Pin x 4mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008389 Catalog Number :

Device Description : Steinmann Pin x 5mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Revolution External Plating System - 00854641008396 Catalog Number :

Device Description : Steinmann Pin x 6mm

Device Class : 2

Duns Number: 080859336

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

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