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) (8) Pin, Fixation, Smooth (HTY) (2)

Premarket Exempt

Clear

Additive Orthopaedic Bone Wedge System - 00850005508106 Catalog Number :

Device Description : Cotton Bone Segment - 16x14x10x5.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508113 Catalog Number :

Device Description : Cotton Bone Segment - 16x14x10x6.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508120 Catalog Number :

Device Description : Cotton Bone Segment - 18x14x10x4.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508137 Catalog Number :

Device Description : Cotton Bone Segment - 18x14x10x5.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508144 Catalog Number :

Device Description : Cotton Bone Segment - 18x14x10x6.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508151 Catalog Number :

Device Description : Cotton Bone Segment - 20x14x10x4.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508168 Catalog Number :

Device Description : Cotton Bone Segment - 20x14x10x5.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedic Bone Wedge System - 00850005508175 Catalog Number :

Device Description : Cotton Bone Segment - 20x14x10x6.5

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Additive Orthopaedics Hammertoe System - 00850005508182 Catalog Number :

Device Description : Additive Orthopaedics Hammertoe Implant - 3.0x3.2x18mm, Non-Cannulated

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Additive Orthopaedics Hammertoe System - 00850005508199 Catalog Number :

Device Description : Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Angled Implant - ST

Device Class : 2

Duns Number: 085503457

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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