IN2BONES USA, LLC

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

Orthopedic Manual Surgical Instrument (LXH) (4) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (3) Guide, Surgical, Instrument (FZX) (3)

Premarket Exempt

No Yes

Clear

In2Bones USA - 00810021860008 Catalog Number :

Device Description : K-wire, S. Trocar, Threaded, .062x6"

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860015 Catalog Number :

Device Description : K-wire, S. Trocar, Threaded, .062x9"

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860022 Catalog Number :

Device Description : 2.5 x 60 mm Drill

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860039 Catalog Number :

Device Description : 1.9 x 50 mm Drill

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860046 Catalog Number :

Device Description : 0.062x3" Olive Wire

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860053 Catalog Number :

Device Description : Lag Drill, Ø3.5

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860060 Catalog Number :

Device Description : Lag Drill, Ø2.7

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Hercules Suture Anchor System - 00810021860169 Catalog Number :

Device Description : Hercules™ Knotless Suture Anchor, 2.5 mm x 8.6 mm

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860176 Catalog Number :

Device Description : Hercules™ Knotless Suture Anchor, 3.5 mm x 12 mm

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860183 Catalog Number :

Device Description : Hercules™ Knotless Anchor, 4.5 mm x 15.5 mm

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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