ADDITIVE ORTHOPAEDICS LLC

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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) (10)

Premarket Exempt

Clear

Additive Orthopaedic Bone Wedge System - 00850005508007 Catalog Number :

Device Description : Evans Bone Segment - 18x18x8

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508014 Catalog Number :

Device Description : Evans Bone Segment - 18x18x10

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508021 Catalog Number :

Device Description : Evans Bone Segment - 18x18x12

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508038 Catalog Number :

Device Description : Evans Bone Segment - 20x20x8

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508045 Catalog Number :

Device Description : Evans Bone Segment - 20x20x10

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508052 Catalog Number :

Device Description : Evans Bone Segment - 20x20x12

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508069 Catalog Number :

Device Description : Evans Bone Segment - 22x22x8

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508076 Catalog Number :

Device Description : Evans Bone Segment - 22x22x10

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508083 Catalog Number :

Device Description : Evans Bone Segment - 22x22x12

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508090 Catalog Number :

Device Description : Cotton Bone Segment - 16x14x10x4.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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