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 Utility Wedge - 00840097503523 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 5 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503530 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 10 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503547 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 0 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503554 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 5 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503561 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 10 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503578 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 0 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503585 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 5 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Utility Wedge - 00840097503592 Catalog Number :

Device Description : Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 10 Degree

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097504506 Catalog Number :

Device Description : Disposable Trial, Cervical Trial Kit w/ Stop, Small Footprint

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument, Cervical Cage Trial - 00840097504513 Catalog Number :

Device Description : Disposable Trial, Cervical Trial Kit w/ Stop, Medium Footprint

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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