Exsomed Corporation

Address:135 Columbia,Aliso Viejo,CA,92656,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

Screw, Fixation, Bone (HWC) (9) Orthopedic Manual Surgical Instrument (LXH) (3) Passer, Wire, Orthopedic (HXI) (3) Bit, Drill (HTW) (1) Gauge, Depth (HTJ) (1)

Premarket Exempt

No Yes

Clear

INnate Implant - B47EXINN9245400 Catalog Number : EXINN924540

Device Description : INnate is a stainless steel bone screw

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

ArcPhix System - B487EXARC9030280 Catalog Number : EXARC903028

Device Description : ArcPhix Compression Screw SystemThe system includes the implant, two guide wires ArcPhix Compression Screw SystemThe system includes the implant, two guide wires, one cannulated drill, and a driver.

Device Class : 1

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC, HXI, LXH, HTW

Prescription Use : Yes

Device Count : 1

ArrowPhix System - B487EXARR9025260 Catalog Number : EXARR902526

Device Description : ArrowPhix Compression Screw SystemThe System includes the implant, two guide wir ArrowPhix Compression Screw SystemThe System includes the implant, two guide wires, and one driver.

Device Class : 1

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC, LXH, HXI

Prescription Use : Yes

Device Count : 1

InFrame Instrument Kit - B487EXINF9120000 Catalog Number : EXINF912000

Device Description : InFrame sterile instrument kit.The kit contains two step guide wires, one cannul InFrame sterile instrument kit.The kit contains two step guide wires, one cannulated drill, one depth gauge

Device Class : 1

Duns Number: 116722111

Premarket Exempt : Yes

Product Code : HXI, LXH, HTJ

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220100 Catalog Number : EXINF922010

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220120 Catalog Number : EXINF922012

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220140 Catalog Number : EXINF922014

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220160 Catalog Number : EXINF922016

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220180 Catalog Number : EXINF922018

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

InFrame Implant - B487EXINF9220200 Catalog Number : EXINF922020

Device Description : InFrame is a stainless steel bone screw.

Device Class : 2

Duns Number: 116722111

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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