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 - M68111000100300 Catalog Number : 1100-01-0030

Device Description : 5.5mm x 30mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100350 Catalog Number : 1100-01-0035

Device Description : 5.5mm x 35mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100400 Catalog Number : 1100-01-0040

Device Description : 5.5mm x 40mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100450 Catalog Number : 1100-01-0045

Device Description : 5.5mm x 45mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100500 Catalog Number : 1100-01-0050

Device Description : 5.5mm x 50mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100550 Catalog Number : 1100-01-0055

Device Description : 5.5mm x 55mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100600 Catalog Number : 1100-01-0060

Device Description : 5.5mm x 60mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100650 Catalog Number : 1100-01-0065

Device Description : 5.5mm x 65mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100700 Catalog Number : 1100-01-0070

Device Description : 5.5mm x 70mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Apelo® / Apelo® MIS - M68111000100750 Catalog Number : 1100-01-0075

Device Description : 5.5mm x 75mm Straight Rod

Device Class : 2

Duns Number: 140801007

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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