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) (9) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HSN) (1)

Premarket Exempt

No Yes

Clear

Paragon 28 Bone Wedge System - 00889795121288 Catalog Number : AOCWO-20-6 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 20-6

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121295 Catalog Number : AOCWO-20-7 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 20-7

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121301 Catalog Number : AOCWO-20-8 TRL

Device Description : Additive Orthopaedics Organic Cotton Wedge Trial, 20-8

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

APEX 3D Total Ankle Replacement System - 00889795121325 Catalog Number : P10-931-I315

Device Description : Total Ankle, Instrument, Poly Trial Insert, Size 3, 15MM, 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 - 00889795121332 Catalog Number : AOCW-16-10 TRL

Device Description : Additive Orthopaedics Cotton Wedge Trial, 16-10

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121349 Catalog Number : AOCW-18-10 TRL

Device Description : Additive Orthopaedics Cotton Wedge Trial, 18-10

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121356 Catalog Number : AOCW-20-10 TRL

Device Description : Additive Orthopaedics Cotton Wedge Trial, 20-10

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121363 Catalog Number : AOCW-16-8 TRL

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

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121370 Catalog Number : AOCW-18-8 TRL

Device Description : Additive Orthopaedics Cotton Wedge Trial, 18-8

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Paragon 28 Bone Wedge System - 00889795121387 Catalog Number : AOCW-20-8 TRL

Device Description : Additive Orthopaedics Cotton Wedge Trial, 20-8

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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