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) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

restor3d, Disposable Instrument, Cervical Cage - 00840097500010 Catalog Number :

Device Description : Disposable Trial, Cervical Cage 001, Small Footprint, 7mm Thickness

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d, Disposable Instrument, Cervical Cage Trial - 00840097500027 Catalog Number :

Device Description : Disposable Trial, Cervical Cage 001, Small Footprint, 8mm Thickness

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500034 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500041 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Cotton, Small Footprint, 5mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500058 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500065 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500072 Catalog Number :

Device Description : Titanium (Ti-6AI-4V) Wedge, Cotton, Medium Footprint, 5mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500089 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500096 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Osteotomy Wedge - 00840097500102 Catalog Number :

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

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

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