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 - M68111000500240 Catalog Number : 1100-05-0024

Device Description : 24mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500260 Catalog Number : 1100-05-0026

Device Description : 26mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500280 Catalog Number : 1100-05-0028

Device Description : 28mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500300 Catalog Number : 1100-05-0030

Device Description : 30mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000500320 Catalog Number : 1100-05-0032

Device Description : 32mm Fixed Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000542480 Catalog Number : 1100-05-4248

Device Description : 42-48mm Variable Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000548540 Catalog Number : 1100-05-4854

Device Description : 48-54mm Variable Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000554600 Catalog Number : 1100-05-5460

Device Description : 54-60mm Variable Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000560660 Catalog Number : 1100-05-6066

Device Description : 60-66mm Variable Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000566720 Catalog Number : 1100-05-6672

Device Description : 66-72mm Variable Cross Connector

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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