CARTIVA, INC

Address:6120 Windward Pkwy Ste 220,Alpharetta,GA,30005,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

Instruments Designed For Press-Fit Osteochondral Implants (QBO) (8) Orthopedic Manual Surgical Instrument (LXH) (1) Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant (PNW) (1)

Premarket Exempt

Clear

Cartiva SCI Placer - 00852897002090 Catalog Number : PLC-10-US

Device Description : Surgical Instrument- 10 mm Placer

Device Class : 1

Duns Number: 078582549

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cartiva SCI Introducer - 00852897002106 Catalog Number : INT-08

Device Description : Surgical Instrument- 8 mm Introducer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Introducer - 00852897002113 Catalog Number : INT-10

Device Description : Surgical Instrument- 10 mm Introducer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Metatarsal Drill Bit - 00852897002120 Catalog Number : MTD-08

Device Description : Surgical Instrument- 8 mm Metatarsal Drill Bit

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Metatarsal Drill Bit - 00852897002137 Catalog Number : MTD-10

Device Description : Surgical Instrument- 10 mm Metatarsal Drill Bit

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Placer - 00852897002144 Catalog Number : PLC-08

Device Description : Surgical Instrument- 8 mm Placer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Placer - 00852897002151 Catalog Number : PLC-10

Device Description : Surgical Instrument- 10 mm Placer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva Disposable Instrument Set - 00852897002205 Catalog Number : MTK-08

Device Description : Surgical Instrument Set- 8 mm

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva Disposable Instrument Set - 00852897002212 Catalog Number : MTK-10

Device Description : Surgical Instrument Set- 10 mm

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva Synthetic Cartilage Implant - 00852897002328 Catalog Number : CAR-06-US

Device Description : 6 mm Synthetic Cartilage Implant

Device Class : 3

Duns Number: 078582549

Premarket Exempt : No

Product Code : PNW

Prescription Use : Yes

Device Count : 1

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