NEWDEAL

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

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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

REAMER (HTO) (10)

Premarket Exempt

No Yes

Clear

Hallu®- LOCK - 10381780044901 Catalog Number :

Device Description : The 14mm diameter metatarsal yellow colored reamer is used to ream and accuratel The 14mm diameter metatarsal yellow colored reamer is used to ream and accurately resurface the articular surface of the metatarse for maximal contact and ultimate snug-fit of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044918 Catalog Number :

Device Description : The 16mm diameter metatarsal blue colored reamer is used to ream and accurately The 16mm diameter metatarsal blue colored reamer is used to ream and accurately resurface the articular surface of the metatarse for maximal contact and ultimate snug-fit of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044925 Catalog Number :

Device Description : The 18mm diameter metatarsal red colored reamer is used to ream and accurately r The 18mm diameter metatarsal red colored reamer is used to ream and accurately resurface the articular surface of the metatarse for maximal contact and ultimate snug-fit of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044932 Catalog Number :

Device Description : The 20mm diameter metatarsal green colored reamer is used to ream and accurately The 20mm diameter metatarsal green colored reamer is used to ream and accurately resurface the articular surface of the metatarse for maximal contact and ultimate snug-fit of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044949 Catalog Number :

Device Description : The 22mm diameter metatarsal brown colored reamer is used to ream and accurately The 22mm diameter metatarsal brown colored reamer is used to ream and accurately resurface the articular surface of the metatarse for maximal contact and ultimate snug-fit of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044956 Catalog Number :

Device Description : The 14mm phalangeal yellow colored reamer is used to ream the articular surface The 14mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044963 Catalog Number :

Device Description : The 16mm phalangeal yellow colored reamer is used to ream the articular surface The 16mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044970 Catalog Number :

Device Description : The 18mm phalangeal yellow colored reamer is used to ream the articular surface The 18mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044987 Catalog Number :

Device Description : The 20mm phalangeal yellow colored reamer is used to ream the articular surface The 20mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Hallu®- LOCK - 10381780044994 Catalog Number :

Device Description : The 22mm phalangeal yellow colored reamer is used to ream the articular surface The 22mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface.It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

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