IN2BONES USA, LLC

Address:6000 POPLAR AVE STE 115,Memphis,TN,38119,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

Screw, Fixation, Bone (HWC) (7) Guide, Surgical, Instrument (FZX) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

IN2BONES USA - 00810021860305 Catalog Number :

Device Description : Threaded Bending Bars

Device Class : 1

Duns Number: 079700711

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CoLink Mini - 00810021860312 Catalog Number :

Device Description : Locking Drill Guide, Ø1.6

Device Class : 1

Duns Number: 079700711

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

CoLink Mini - 00810021860329 Catalog Number :

Device Description : Locking Drill Guide, Ø1.9

Device Class : 1

Duns Number: 079700711

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860336 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X8MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860343 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X9MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860350 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X10MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860367 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X11MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860374 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X12MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860381 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X13MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CoLink - 00810021860398 Catalog Number :

Device Description : LOW-PRO CORTICAL SCREW, Ø2.4X14MM

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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