NEWDEAL

Address:Immeuble S�quoia 2, 97 all�e Alexandre Borodine,Saint Priest Rhone,FR

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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

GAUGE, DEPTH (HTJ) (10)

Premarket Exempt

No Yes

Clear

CALCANEA™ - 10381780044802 Catalog Number :

Device Description : The depth gauge is used to evaluate the appropriate screw length to implant.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

Hallu®-FIX - 10381780044819 Catalog Number :

Device Description : The depth gauge is used to choose the length of the fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

TIBIAXYS® - 10381780044826 Catalog Number :

Device Description : The depth gauge is used to choose the length of the fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

SURFIX® - 10381780044833 Catalog Number :

Device Description : The depth gauge for 3.5 mm screws is used to choose the length of the fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

SURFIX® - 10381780044840 Catalog Number :

Device Description : The depth gauge for 4.5 mm screws is used to choose the length of the fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

SURFIX® - 10381780044857 Catalog Number :

Device Description : The depth gauge for 6.5 mm screws is used to choose the length of the fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044864 Catalog Number :

Device Description : The depth gauge is used to choose length of fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

PANTA® - 10381780044871 Catalog Number :

Device Description : The depth gauge is used to choose length of fixation screws.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

FOREFOOT SOLUTIONS™ - 10381780044888 Catalog Number :

Device Description : The depth gauge is used by the surgeon to choose the length of the screw or the The depth gauge is used by the surgeon to choose the length of the screw or the staple to implant.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

SURFIX® - 10381780044895 Catalog Number :

Device Description : The SURFIX® length gauge is used to estimate the length of the screws that will The SURFIX® length gauge is used to estimate the length of the screws that will be necessary during the osteosynthesis.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

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