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

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (6) Orthopedic Manual Surgical Instrument (LXH) (4)

Premarket Exempt

No Yes

Clear

Hercules Suture Anchor System - 00810021860190 Catalog Number :

Device Description : Hercules™ Knotless Anchor, 5.5 mm x 19.5 mm

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860206 Catalog Number :

Device Description : Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and tapered 1/2 circle needles

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860213 Catalog Number :

Device Description : Hercules™ FT Suture Anchor, 2.5 mm x 7.5 mm with two 2-0 BightForce Suture and Hercules™ FT Suture Anchor, 2.5 mm x 7.5 mm with two 2-0 BightForce Suture and tapered 1/2 circle needles

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860220 Catalog Number :

Device Description : Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and tapered 1/2 circle needles

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860237 Catalog Number :

Device Description : Hercules™ FT Suture Anchor, 4.5 mm x 13.5 mm with two #2 BightForce Suture and Hercules™ FT Suture Anchor, 4.5 mm x 13.5 mm with two #2 BightForce Suture and tapered 1/2 circle needles

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Hercules Suture Anchor System - 00810021860244 Catalog Number :

Device Description : Hercules™ FT Suture Anchor, 5.5 mm x 16.5 mm with two #2 BightForce Suture and Hercules™ FT Suture Anchor, 5.5 mm x 16.5 mm with two #2 BightForce Suture and tapered 1/2 circle needles

Device Class : 2

Duns Number: 079700711

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

In2Bones USA - 00810021860251 Catalog Number :

Device Description : CoLink Bone Graft Harvester, 6mm - Sterile, Disposable

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860268 Catalog Number :

Device Description : CoLink Bone Graft Harvester, 8mm - Sterile, Disposable

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860275 Catalog Number :

Device Description : CoLink Bone Graft Harvester, 10mm, Sterile, Disposable

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

In2Bones USA - 00810021860282 Catalog Number :

Device Description : CoLink Bone Graft Harvester, 12mm, Sterile, Disposable

Device Class : 1

Duns Number: 079700711

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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