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

Plate, fixation, bone (HRS) (4) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HSN) (3) TRAY, SURGICAL, INSTRUMENT (FSM) (2) Orthopedic manual surgical instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Paragon 28 Bone Wedge System - 00889795120809 Catalog Number : AONLS3024

Device Description : AO NON-LCKG SCW 3.0MM X 24MM

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795120816 Catalog Number : AONLS3026

Device Description : AO NON-LCKG SCW 3.0MM X 26MM

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795120823 Catalog Number : AONLS3028

Device Description : AO NON-LCKG SCW 3.0MM X 28MM

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795120830 Catalog Number : AONLS3030

Device Description : AO NON-LCKG SCW 3.0MM X 30MM

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Monkey Rings™ External Fixation System - 00889795120908 Catalog Number : P45-901-DISH

Device Description : Case Dishwasher, Case 1 of 4

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Monkey Rings™ External Fixation System - 00889795120915 Catalog Number : P45-902-BASE

Device Description : Case Base, Case 2 of 4

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795120922 Catalog Number : P10-851-TP12

Device Description : APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 1-2

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795120939 Catalog Number : P10-851-TP34

Device Description : APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 3-4

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795120946 Catalog Number : P10-851-TP56

Device Description : APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 5-6

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

Monkey Rings™ External Fixation System - 00889795120953 Catalog Number : P45-513-0004

Device Description : Tubular Wrench, 10mm

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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