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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

No Yes

Clear

restor3d Cervical Cage - 00840097500799 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx10Hx7

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500805 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx11Hx0

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500812 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx11Hx7

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500829 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx12Hx0

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Cervical Cage - 00840097500836 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Cervical Cage, 17Wx15Dx12Hx7

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : ODP

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097500850 Catalog Number :

Device Description : Disposable Trial, Cervical Cage, Small Footprint, 5mm Thickness, 0 degrees

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097500867 Catalog Number :

Device Description : Disposable Trial, Cervical Cage, Small Footprint, 5mm Thickness, 7 degrees

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097500874 Catalog Number :

Device Description : Disposable Trial, Cervical Cage, Small Footprint, 6mm Thickness, 0 degrees

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097500881 Catalog Number :

Device Description : Disposable Trial, Cervical Cage, Small Footprint, 6mm Thickness, 7 degrees

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097500898 Catalog Number :

Device Description : Disposable Trial, Cervical Cage, Small Footprint, 7mm Thickness, 0 degrees

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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