Orthosoft 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

Shoulder Arthroplasty Implantation System (QHE) (8) Orthopedic Stereotaxic Instrument (OLO) (2)

Premarket Exempt

No Yes

Clear

ROSA® KNEE NEXGEN® ID PLATE - 00889024516816 Catalog Number : 20-8020-061-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ROSA® KNEE VANGUARD® ID PLATE - 00889024516823 Catalog Number : 20-8020-062-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

TMR+™ Shoulder Guide and Bone Model Left - 00889024563339 Catalog Number : 20-8090-001-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

TMR+™ Shoulder Guide and Bone Model Right - 00889024563346 Catalog Number : 20-8090-001-02

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Total Shoulder Guide and Bone Model Left - 00889024563353 Catalog Number : 20-8090-002-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Total Shoulder Guide and Bone Model Right - 00889024563360 Catalog Number : 20-8090-002-02

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left - 00889024563377 Catalog Number : 20-8090-003-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right - 00889024563384 Catalog Number : 20-8090-003-02

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left - 00889024563391 Catalog Number : 20-8090-004-01

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right - 00889024563407 Catalog Number : 20-8090-004-02

Device Class : 2

Duns Number: 205670032

Premarket Exempt : No

Product Code : QHE

Prescription Use : Yes

Device Count : 1

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