ATLAS SPINE, INC.

Address:1555 Jupiter Park Dr Ste 1,JUPITER,FL,33458,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

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10)

Premarket Exempt

No Yes

Clear

Apelo® / Apelo® MIS - M68111000300750 Catalog Number : 1100-03-0075

Device Description : 5.5mm x 75mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300800 Catalog Number : 1100-03-0080

Device Description : 5.5mm x 80mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300850 Catalog Number : 1100-03-0085

Device Description : 5.5mm x 85mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300900 Catalog Number : 1100-03-0090

Device Description : 5.5mm x 90mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300950 Catalog Number : 1100-03-0095

Device Description : 5.5mm x 95mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000301000 Catalog Number : 1100-03-0100

Device Description : 5.5mm x 100mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000301050 Catalog Number : 1100-03-0105

Device Description : 5.5mm x 105mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000301100 Catalog Number : 1100-03-0110

Device Description : 5.5mm x 110mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500200 Catalog Number : 1100-05-0020

Device Description : 20mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500220 Catalog Number : 1100-05-0022

Device Description : 22mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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