IVY SPORTS MEDICINE LLC

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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

Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (4) Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen (OLC) (3)

Premarket Exempt

Clear

Collagen Meniscus Implant CMI® - M92843001 Catalog Number : 4300

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : OLC

Prescription Use : Yes

Device Count : 1

Collagen Meniscus Implant CMI® - M92843011 Catalog Number : 4301

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : OLC

Prescription Use : Yes

Device Count : 1

Collagen Meniscus Implant CMI® - M92843021 Catalog Number : 4302

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : OLC

Prescription Use : Yes

Device Count : 1

SharpShooter® Surgical Suture - M92847011 Catalog Number : 4701

Device Description : Polyester Suture for SharpShooter®

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Stryker AIR™ - M92847201 Catalog Number : 4720

Device Description : Stryker AIR™ All-Inside Meniscal Repair

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

IvyAIR Meniscus System, Curved - M92847301 Catalog Number : 4730

Device Description : IvyAIR Meniscus Repair System, Curved

Device Class : 2

Duns Number: 046226406

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

SharpShooter® Surgical Suture - M928HS47041 Catalog Number : HS4704

Device Description : UHMWPE Suture for SharpShooter®

Device Class :

Duns Number: 046226406

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

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