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

BIT, DRILL (HTW) (4) SCREWDRIVER (HXX) (3) Guide, surgical, instrument (FZX) (2) STARTER, BONE SCREW (HWD) (1)

Premarket Exempt

Clear

EPIX Lag Screw Step Drill Stop - B2215000002500 Catalog Number : 5000-00250

Device Description : Drill Bit

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

EPIX Lateral Cortex Drill - B2215000002550 Catalog Number : 5000-00255

Device Description : Drill Bit

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Retaining Rod - B2215000002600 Catalog Number : 5000-00260

Device Description : Screwdriver

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

EPIX LAG Screw Driver - B2215000002700 Catalog Number : 5000-00270

Device Description : Screwdriver

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Compression Nut - B2215000002800 Catalog Number : 5000-00280

Device Description : Screwdriver

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

EPIX Distal Locking Outer Sleeve - B2215000002900 Catalog Number : 5000-00290

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Distal Locking Trocar - B2215000003000 Catalog Number : 5000-00300

Device Description : Distal Locking Trocar

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HWD

Prescription Use : Yes

Device Count : 1

EPIX Distal Drill Guide - B2215000003100 Catalog Number : 5000-00310

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Distal Locking Drill - B2215000003200 Catalog Number : 5000-00320

Device Description : Drill Bit

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

EPIX Distal Locking Drill - B2215000003210 Catalog Number : 5000-00321

Device Description : Drill Bit

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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