Link Bio Corp

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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

Tray, Surgical, Instrument (FSM) (9) Template (HWT) (1)

Premarket Exempt

Yes

Clear

LinkBio Instrument - 00810022400005 Catalog Number :

Device Description : SL Valgus Block with Drill Holes

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401484 Catalog Number : MC100F

Device Description : LinkBio Instrument Tray (Mega C): Mega C 100mm Reamers and 100mm Femoral Stem Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401491 Catalog Number :

Device Description : LinkBio Instrument Trays (Mega C): Mega C 130mm Reamers and 130mm Femoral Stem Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401507 Catalog Number :

Device Description : LinkBio Instrument Trays (Mega C): Mega C 160mm Reamers and 160mm Femoral Stem Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401514 Catalog Number :

Device Description : LinkBio Instrument Tray (Mega C): Mega C Classic Femoral & Tibia Prep Inst. With Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401521 Catalog Number :

Device Description : LinkBio Instrument Trays (Mega C): Mega C Classic Femoral & Tibia Augments and Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401538 Catalog Number :

Device Description : LinkBio Instrument Tray (Mega C): Mega C SL Femoral, Tibia Trials & Augments

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401545 Catalog Number :

Device Description : LinkBio Instrument Tray (Mega C): Mega C General Tibia Stem Trials and Extraction Tools

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LinkBio Instrument - 00810022401552 Catalog Number :

Device Description : LinkBio Instrument Tray (Mega C): Mega C SL Tibia Prep Instruments

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

LinkBio Instrument - 00810022401569 Catalog Number :

Device Description : LinkBio Instruments Tray (Mega C): Mega C Stem Segments/Push Thru/Intercalary Trials

Device Class : 1

Duns Number: 827608774

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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