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) (5) BIT, DRILL (HTW) (1) GAUGE, DEPTH (HTJ) (1) REAMER (HTO) (1) STARTER, BONE SCREW (HWD) (1) TAP, BONE (HWX) (1)

Premarket Exempt

Clear

EPIX Multi-Hole Trocar - B2215000001400 Catalog Number : 5000-00140

Device Description : Multi-Hole Trocar

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Conical Reamer - B2215000001500 Catalog Number : 5000-00150

Device Description : Reamer

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

EPIX Impactor - B2215000001700 Catalog Number : 5000-00170

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 Sleeve - B2215000001800 Catalog Number : 5000-00180

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 Trocar - B2215000001900 Catalog Number : 5000-00190

Device Description : Bone Screw Starter

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HWD

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Guidewire Sleeve - B2215000002000 Catalog Number : 5000-00200

Device Description : Surgical instrument guide

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

EPIX Thread Tipped Guide Wire (3.2mm x 515mm) - B2215000002100 Catalog Number : 5000-00210

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 Ruler - B2215000002200 Catalog Number : 5000-00220

Device Description : Depth Gauge

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Tap - B2215000002300 Catalog Number : 5000-00230

Device Description : Bone tap

Device Class : 1

Duns Number: 084913303

Premarket Exempt : No

Product Code : HWX

Prescription Use : Yes

Device Count : 1

EPIX Lag Screw Step Drill - B2215000002400 Catalog Number : 5000-00240

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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