PARAGON 28, INC.

Address:44 Riverdale Avenue,Monmouth Bch,NJ,07750,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

PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HSN) (10)

Premarket Exempt

No Yes

Clear

APEX 3D Total Ankle Replacement System - 00889795121493 Catalog Number : P10-931-I411

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 11MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121509 Catalog Number : P10-931-I412

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 12MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121516 Catalog Number : P10-931-I413

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 13MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121523 Catalog Number : P10-931-I414

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 14MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121530 Catalog Number : P10-931-I415

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 15MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121547 Catalog Number : P10-931-I416

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 16MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121554 Catalog Number : P10-931-I417

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 17MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121561 Catalog Number : P10-931-I418

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 18MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121578 Catalog Number : P10-931-I419

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 19MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121585 Catalog Number : P10-931-I420

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 4, 20MM, 3.75MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

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