ONKOS SURGICAL, INC.

Address:77 E HALSEY RD,Parsippany,NJ,07054,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

TRAY, SURGICAL, INSTRUMENT (FSM) (10)

Premarket Exempt

No Yes

Clear

ELEOS™ Limb Salvage System - B27800103000210 Catalog Number : 001-03-00021

Device Description : ELEOS™ INSTRUMENTATION TRAY, 21

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ Limb Salvage System - B27800103000220 Catalog Number : 001-03-00022

Device Description : ELEOS™ INSTRUMENTATION TRAY, 22

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000280 Catalog Number : 001-03-00028

Device Description : ELEOS™ FULL TRAY LID

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000290 Catalog Number : 001-03-00029

Device Description : ELEOS™ HALF TRAY LID

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100010 Catalog Number : 001-03-10001

Device Description : ELEOS™ INSTRUMENTATION TRAY, REAMERS, TRAY 1 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100020 Catalog Number : 001-03-10002

Device Description : ELEOS™ INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100030 Catalog Number : 001-03-10003

Device Description : ELEOS™ INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100040 Catalog Number : 001-03-10004

Device Description : ELEOS™ INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100050 Catalog Number : 001-03-10005

Device Description : ELEOS™ INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103100060 Catalog Number : 001-03-10006

Device Description : ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6 - COMPLETE

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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