Novapproach Spine LLC

Address:13900 Tech City Circle,Alachua,FL,32615,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

Intervertebral fusion device with bone graft, lumbar (MAX) (10) Intervertebral fusion device with integrated fixation, lumbar (OVD) (10)

Premarket Exempt

Clear

OneLIF™ - G07001010710070 Catalog Number : 010-107-1007

Device Description : OneLIF Interbody, Small, 7 Degree, 10mm X 7mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : OVD, MAX

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001010712090 Catalog Number : 010-107-1209

Device Description : OneLIF Interbody, Small, 7 Degree, 12mm X 9mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : OVD, MAX

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001010714110 Catalog Number : 010-107-1411

Device Description : OneLIF Interbody, Small, 7 Degree, 14mm X 11mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : OVD, MAX

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001010716130 Catalog Number : 010-107-1613

Device Description : OneLIF Interbody, Small, 7 Degree, 16mm X 13mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : MAX, OVD

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011310060 Catalog Number : 010-113-1006

Device Description : OneLIF Interbody, Small, 13 Degree, 10mm X 6mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : MAX, OVD

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011312080 Catalog Number : 010-113-1208

Device Description : OneLIF Interbody, Small, 13 Degree, 12mm X 8mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : MAX, OVD

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011314100 Catalog Number : 010-113-1410

Device Description : OneLIF Interbody, Small, 13 Degree, 14mm X 10mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : MAX, OVD

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011316120 Catalog Number : 010-113-1612

Device Description : OneLIF Interbody, Small, 13 Degree, 16mm X 12mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : OVD, MAX

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011914070 Catalog Number : 010-119-1407

Device Description : OneLIF Interbody, Small, 19 Degree, 14mm X 7mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : OVD, MAX

Prescription Use : Yes

Device Count : 1

OneLIF™ - G07001011916090 Catalog Number : 010-119-1609

Device Description : OneLIF Interbody, Small, 19 Degree, 16mm X 9mm

Device Class : 2

Duns Number: 059260001

Premarket Exempt : No

Product Code : MAX, OVD

Prescription Use : Yes

Device Count : 1

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