ORTHOSENSOR INC

Address:1855 Griffin Road,Dania Beach,FL,33004,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

Intraoperative Orthopedic Joint Assessment Aid (ONN) (10)

Premarket Exempt

No Yes

Clear

VERASENSE - 00816818020402 Catalog Number : ZMR-NGCRCH70

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

VERASENSE - 00816818020419 Catalog Number : ZMR-NGPSCD34

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

VERASENSE - 00816818020426 Catalog Number : ZMR-NGPSEF34

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

VERASENSE - 00816818020433 Catalog Number : ZMR-NGPSEF56

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020440 Catalog Number : 05000-001

Device Description : LinkStation MINI with United States and Canada power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020457 Catalog Number : 05000-002

Device Description : LinkStation MINI with Australia and New Zealand power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020464 Catalog Number : 05000-003

Device Description : LinkStation MINI with Continental Europe/ Korea power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020471 Catalog Number : 05000-004

Device Description : LinkStation MINI with United Kingdom and Ireland power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020488 Catalog Number : 05000-005

Device Description : LinkStation MINI with Italy power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

LinkStation MINI - 00816818020495 Catalog Number : 05000-006

Device Description : LinkStation MINI with Switzerland power cord

Device Class : 2

Duns Number: 005788130

Premarket Exempt : No

Product Code : ONN

Prescription Use : Yes

Device Count : 1

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