Epix Orthopaedics Inc.

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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

Guide, surgical, instrument (FZX) (7) HAMMER, SURGICAL (FZY) (1) Orthopedic tray (OJH) (1) SCREWDRIVER (HXX) (1)

Premarket Exempt

Clear

EPIX Sterilization Case - B2215000000010 Catalog Number : 5000-00001

Device Description : Orthopedic Tray

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

EPIX Angle Setting Fixture and Lag Screw Pointer - B2215000000200 Catalog Number : 5000-00020

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZY

Prescription Use : Yes

Device Count : 1

EPIX Angle Adjust Driver - B2215000000300 Catalog Number : 5000-00030

Device Description : Screwdriver

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

EPIX DTS Bolt - B2215000000400 Catalog Number : 5000-00040

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX DTS Bolt Driver - B2215000000500 Catalog Number : 5000-00050

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX DTS (Dynamic Targeting System) - B2215000000600 Catalog Number : 5000-00060

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Trial - B2215000000700 Catalog Number : 5000-00070

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Ball Tipped Guide Wire - B2215000000900 Catalog Number : 5000-00090

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Proximal Reamer Sleeve - B2215000001200 Catalog Number : 5000-00120

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Off Set Proximal Reamer Sleeve - B2215000001300 Catalog Number : 5000-00130

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

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