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 - M68111001000550 Catalog Number : 1100-10-0055

Device Description : 5.5mm x 55mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000600 Catalog Number : 1100-10-0060

Device Description : 5.5mm x 60mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000650 Catalog Number : 1100-10-0065

Device Description : 5.5mm x 65mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000700 Catalog Number : 1100-10-0070

Device Description : 5.5mm x 70mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000750 Catalog Number : 1100-10-0075

Device Description : 5.5mm x 75mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000800 Catalog Number : 1100-10-0080

Device Description : 5.5mm x 80mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000850 Catalog Number : 1100-10-0085

Device Description : 5.5mm x 85mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000900 Catalog Number : 1100-10-0090

Device Description : 5.5mm x 90mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001000950 Catalog Number : 1100-10-0095

Device Description : 5.5mm x 95mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001001000 Catalog Number : 1100-10-0100

Device Description : 5.5mm x 100mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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