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 - M68111001001050 Catalog Number : 1100-10-0105

Device Description : 5.5mm x 105mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001001100 Catalog Number : 1100-10-0110

Device Description : 5.5mm x 110mm Contoured Secure Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400300 Catalog Number : 1100-14-0030

Device Description : 5.5mm x 30mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400350 Catalog Number : 1100-14-0035

Device Description : 5.5mm x 35mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400400 Catalog Number : 1100-14-0040

Device Description : 5.5mm x 40mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400450 Catalog Number : 1100-14-0045

Device Description : 5.5mm x 45mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400500 Catalog Number : 1100-14-0050

Device Description : 5.5mm x 50mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400550 Catalog Number : 1100-14-0055

Device Description : 5.5mm x 55mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400600 Catalog Number : 1100-14-0060

Device Description : 5.5mm x 60mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111001400650 Catalog Number : 1100-14-0065

Device Description : 5.5mm x 65mm MIS Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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