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

Yes No

Clear

Apelo® / Apelo® MIS - M68111000105000 Catalog Number : 1100-01-0500

Device Description : 5.5mm x 500mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300300 Catalog Number : 1100-03-0030

Device Description : 5.5mm x 30mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300350 Catalog Number : 1100-03-0035

Device Description : 5.5mm x 35mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300400 Catalog Number : 1100-03-0040

Device Description : 5.5mm x 40mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300450 Catalog Number : 1100-03-0045

Device Description : 5.5mm x 45mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300500 Catalog Number : 1100-03-0050

Device Description : 5.5mm x 50mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300550 Catalog Number : 1100-03-0055

Device Description : 5.5mm x 55mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300600 Catalog Number : 1100-03-0060

Device Description : 5.5mm x 60mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300650 Catalog Number : 1100-03-0065

Device Description : 5.5mm x 65mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000300700 Catalog Number : 1100-03-0070

Device Description : 5.5mm x 70mm Contoured Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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