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

Orthopedic Manual Surgical Instrument (LXH) (6) Bone Wedge (PLF) (4)

Premarket Exempt

No Yes

Clear

restor3d Osteotomy Wedge - 00840097504759 Catalog Number :

Device Description : Ti Anatomic Cotton Wedge 002, Small Footprint, 7mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : Yes

Device Count : 1

restor3d Osteotomy Wedge - 00840097504766 Catalog Number :

Device Description : Ti Anatomic Cotton Wedge 002, Small Footprint, 8mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : Yes

Device Count : 1

restor3d Osteotomy Wedge - 00840097504773 Catalog Number :

Device Description : Ti Anatomic Cotton Wedge 002, Small Footprint, 10mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : Yes

Device Count : 1

restor3d Osteotomy Wedge - 00840097504780 Catalog Number :

Device Description : Ti Anatomic Cotton Wedge 002, Small Footprint, 12mm Thickness

Device Class : 2

Duns Number: 080819836

Premarket Exempt : No

Product Code : PLF

Prescription Use : Yes

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504858 Catalog Number :

Device Description : Cervical Trial Kit with Stop, Small Footprint, 5-10mm Height, 7 degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504865 Catalog Number :

Device Description : Cervical Trial Kit with Stop, Medium Footprint, 5-10mm Height, 7 degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504872 Catalog Number :

Device Description : Cervical Trial Kit with Stop, Large Footprint, 5-10mm Height, 7 degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504889 Catalog Number :

Device Description : Cervical Trial Kit without Stop, Small Footprint, 5-10mm Thickness, 7 Degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504896 Catalog Number :

Device Description : Cervical Trial Kit without Stop, Medium Footprint, 5-10mm Thickness, 7 Degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

restor3d Disposable Instrument Kit - 00840097504902 Catalog Number :

Device Description : Cervical Trial Kit without Stop, Large Footprint, 5-10mm Thickness, 7 Degree

Device Class : 1

Duns Number: 080819836

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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