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™ - B27800103000010 Catalog Number : 001-03-00001

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000020 Catalog Number : 001-03-00002

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000030 Catalog Number : 001-03-00003

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000040 Catalog Number : 001-03-00004

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000050 Catalog Number : 001-03-00005

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000060 Catalog Number : 001-03-00006

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

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000070 Catalog Number : 001-03-00007

Device Description : ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000080 Catalog Number : 001-03-00008

Device Description : ELEOS™ INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000090 Catalog Number : 001-03-00009

Device Description : ELEOS™ INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000100 Catalog Number : 001-03-00010

Device Description : ELEOS™ INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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