CARTIVA, INC

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

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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) Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant (PNW) (1)

Premarket Exempt

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Cartiva Synthetic Cartilage Implant - 00852897002335 Catalog Number : CAR-12-US

Device Description : 12 mm Synthetic Cartilage Implant

Device Class : 3

Duns Number: 078582549

Premarket Exempt : No

Product Code : PNW

Prescription Use : Yes

Device Count : 1

Cartiva Disposable Instrument Set - 00852897002342 Catalog Number : MTS-08

Device Description : Surgical Instrument Set- 8 mm Disposable

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva Disposable Instrument Set - 00852897002359 Catalog Number : MTS-10

Device Description : Surgical Instrument Set- 10 mm Disposable

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Introducer - 00852897002946 Catalog Number : INT-12

Device Description : Surgical Instrument- 12 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 - 00852897002953 Catalog Number : MTD-12

Device Description : Surgical Instrument- 12 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 - 00852897002960 Catalog Number : PLC-12

Device Description : Surgical Instrument- 12 mm Placer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

Cartiva SCI Introducer - 00852897002977 Catalog Number : INT-06-G1

Device Description : Surgical Instrument- 6 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 - 00852897002984 Catalog Number : MTD-06-G1

Device Description : Surgical Instrument- 6 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 - 00852897002991 Catalog Number : PLC-06-G1

Device Description : Surgical Instrument- 6 mm Placer

Device Class : 2

Duns Number: 078582549

Premarket Exempt : No

Product Code : QBO

Prescription Use : Yes

Device Count : 1

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