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

PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HSN) (6) Plate, fixation, bone (HRS) (2) Orthopedic manual surgical instrument (LXH) (1) PASSER, WIRE, ORTHOPEDIC (HXI) (1)

Premarket Exempt

No Yes

Clear

Paragon 28 Bone Wedge System - 00889795121394 Catalog Number : AOTRL-01-01

Device Description : Additive Orthopaedics General Trial Caddy Base

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121400 Catalog Number : AOTRL-01-02

Device Description : Additive Orthopaedics General Trial Caddy Lid

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Grappler™ Suture Anchor System - 00889795121417 Catalog Number : P44-943-3215

Device Description : K-Wire with depth markings, 3.2mm 15cm

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121424 Catalog Number : P10-931-I316

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 16MM, 3.50MM ANT/POST Offset, PPSU

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

Monkey Rings™ External Fixation System - 00889795121431 Catalog Number : P45-517-0001

Device Description : Rapid Nut Allen Wrench

Device Class : 1

Duns Number: 042961576

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121448 Catalog Number : P10-952-TL00-05

Device Description : APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HSN

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121455 Catalog Number : P10-931-I317

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 17MM, 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 - 00889795121462 Catalog Number : P10-931-I318

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 18MM, 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 - 00889795121479 Catalog Number : P10-931-I319

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 19MM, 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 - 00889795121486 Catalog Number : P10-931-I320

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 20MM, 3.50MM 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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