PARAGON 28, INC.

Address:14445 Grasslands Dr.,Englewood,CO,80112,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) (5) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HSN) (2) TRAY, SURGICAL, INSTRUMENT (FSM) (2) PASSER, WIRE, ORTHOPEDIC (HXI) (1)

Premarket Exempt

No Yes

Clear

Monkey Rings™ External Fixation System - 00889795120960 Catalog Number : P45-903-CAD1

Device Description : Case 3 K-Wire Caddy

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Monkey Rings™ External Fixation System - 00889795120977 Catalog Number : P45-903-CAD2

Device Description : Case 3 Fasterner Caddy

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Monster Screw System - 00889795120984 Catalog Number : P99-192-2615

Device Description : K-wire, Single Ended Trocar Tip, SMOOTH, 2.6 x 150mm

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121158 Catalog Number : AOCWO-16-5 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 16-5

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121165 Catalog Number : AOCWO-16-6 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 16-6

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121172 Catalog Number : AOCWO-16-7 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 16-7

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121189 Catalog Number : AOCWO-16-8 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 16-8

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121202 Catalog Number : P10-931-I313

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 13MM, 3.50MM 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 - 00889795121264 Catalog Number : P10-931-I314

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 14MM, 3.50MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121271 Catalog Number : AOCWO-20-5 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 20-5

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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