Restor3d

Address:311 W Corporation St,Durham,NC,27701,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

Bone Wedge (PLF) (7) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3)

Premarket Exempt

No Yes

Clear

restor3d Osteotomy Wedge - 00840097500119 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Small Footprint, 12mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500126 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Medium Footprint, 8mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500133 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Medium Footprint, 10mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500140 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Medium Footprint, 12mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500157 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Large Footprint, 8mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500164 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Large Footprint, 10mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500171 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Evans, Large Footprint, 12mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500362 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 14Wx11Dx5Hx0

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500379 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 14Wx11Dx5Hx7

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500386 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 14Wx11Dx6Hx0

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

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