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

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (6) Orthopedic Manual Surgical Instrument (LXH) (3) Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (1)

Premarket Exempt

No Yes

Clear

HemiCAP® - M52861050028A0 Catalog Number : 6105-0028-A

Device Description : 10.5mm Fixation Component

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

HemiCAP® - M52861050028W0 Catalog Number : 6105-0028-W

Device Description : 10.5mm Fixation Component

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

HemiCAP® - M52861250035A0 Catalog Number : 6125-0035-A

Device Description : Taper Post, 9.0mm x 30mm Lg

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

HemiCAP® - M52861250035W0 Catalog Number : 6125-0035-W

Device Description : Taper Post, 9.0mm x 30mm Lg

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528700713000 Catalog Number : 7007-1300

Device Description : 2mm Guide Pin, TG (Single)

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528800040100 Catalog Number : 8000-4010

Device Description : DISPOSABLE REAMER, 40MM

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528800712000 Catalog Number : 8007-1200

Device Description : Kit, 2.5mm Guide Pin (single)

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HemiCAP® - M528800712050 Catalog Number : 8007-1205

Device Description : Kit, 2.5mm Guide Pin (5 Pk)

Device Class : 1

Duns Number: 144666109

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HemiCAP® - M52880850025A0 Catalog Number : 8085-0025-A

Device Description : 8.5mm FIXATION COMPONENT, Humeral Head

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

HemiCAP® - M52880850025W0 Catalog Number : 8085-0025-W

Device Description : Taper Post, 10.0mm x 31mm Lg

Device Class : 2

Duns Number: 144666109

Premarket Exempt : No

Product Code : HSD

Prescription Use : Yes

Device Count : 1

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