Medshape, Inc.

Address:1575 NORTHSIDE DR NW STE 440,Atlanta,GA,30318,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

Bit, Drill (HTW) (6) Kit, Surgical Instrument, Disposable (KDD) (6) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (4) Screw, Fixation, Bone (HWC) (4)

Premarket Exempt

No Yes

Clear

Morphix - M9701000042550 Catalog Number :

Device Description : MORPHIX Foot & Ankle 5.5mm x 11mm Anchor with two sutures, each double armed with needles

Device Class : 2

Duns Number: 601306413

Premarket Exempt : No

Product Code : MBI, HWC

Prescription Use : Yes

Device Count : 1

Morphix - M9701000042550A Catalog Number :

Device Description : MORPHIX Foot & Ankle 5.5mm x 11mm Anchor with two sutures, each double armed with needles

Device Class : 2

Duns Number: 601306413

Premarket Exempt : No

Product Code : HWC, MBI

Prescription Use : Yes

Device Count : 1

Morphix - M9701000100250 Catalog Number :

Device Description : MORPHIX 2.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : HTW, KDD

Prescription Use : Yes

Device Count : 1

Morphix - M97010001002502 Catalog Number :

Device Description : MORPHIX 2.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : KDD, HTW

Prescription Use : Yes

Device Count : 1

Morphix - M9701000100350 Catalog Number :

Device Description : MORPHIX 3.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : HTW, KDD

Prescription Use : Yes

Device Count : 1

Morphix - M97010001003503 Catalog Number :

Device Description : MORPHIX 3.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : KDD, HTW

Prescription Use : Yes

Device Count : 1

Morphix - M9701000100450 Catalog Number :

Device Description : MORPHIX 4.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : KDD, HTW

Prescription Use : Yes

Device Count : 1

Morphix - M97010001004504 Catalog Number :

Device Description : MORPHIX 4.5mm Single Use Drill and Guide Procedure Pack, Sterile

Device Class : 1

Duns Number: 601306413

Premarket Exempt : Yes

Product Code : HTW, KDD

Prescription Use : Yes

Device Count : 1

ExoShape - M97011000006280 Catalog Number :

Device Description : EXOSHAPE Deployment Cartridge, 6mm x 28mm, Angled-Back

Device Class : 2

Duns Number: 601306413

Premarket Exempt : No

Product Code : HWC, MBI

Prescription Use : Yes

Device Count : 1

ExoShape - M97011000006280B Catalog Number :

Device Description : EXOSHAPE Deployment Cartridge, 6mm x 28mm, Angled-Back

Device Class : 2

Duns Number: 601306413

Premarket Exempt : No

Product Code : MBI, HWC

Prescription Use : Yes

Device Count : 1

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