ARTHROSURFACE INCORPORATED

Address:28 FORGE PARKWAY,FRANKLIN,MA,02038,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

Orthopedic Manual Surgical Instrument (LXH) (5) Screw, Fixation, Bone (HWC) (5)

Premarket Exempt

No Yes

Clear

CheckMate® - M5284F0140220 Catalog Number : 4F01-4022

Device Description : Screw, 3.5mm, Interfragment, 22mm

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CheckMate® - M5284F0140240 Catalog Number : 4F01-4024

Device Description : Screw, 3.5mm, Interfragment, 24mm

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CheckMate® - M5284F0140260 Catalog Number : 4F01-4026

Device Description : Screw, 3.5mm, Interfragment, 26mm

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CheckMate® - M5284F0140280 Catalog Number : 4F01-4028

Device Description : Screw, 3.5mm, Interfragment, 28mm

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

CheckMate® - M5284F0140300 Catalog Number : 4F01-4030

Device Description : Screw, 3.5mm, Interfragment, 30mm

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Nano fx® - M528550010200 Catalog Number : 5500-1020

Device Description : NanoFx, Guide, 15 Degree

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Nano fx® - M528550033100 Catalog Number : 5500-3310

Device Description : Guide, Hip, 15o Nanofracture

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Nano fx® - M528550040100 Catalog Number : 5500-4010

Device Description : Guide, ANKLE, Nano Fracture

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528600712000 Catalog Number : 6007-1200

Device Description : Kit, Guide Pin (single) Hip/Shoulder

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528600712050 Catalog Number : 6007-1205

Device Description : Kit, Guide Pin (5 pk) Hip/Shoulder

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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