restor3d Utility Wedge

GUDID 00840097503318

Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 5 Degree

Restor3d

Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized Metallic osteotomy fusion cage, non-customized
Primary Device ID00840097503318
NIH Device Record Key5d5dfef6-cfc7-4f1f-a6fb-14e1bcac0514
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Utility Wedge
Version Model Number1105-2719140505L
Company DUNS080819836
Company NameRestor3d
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097503318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLFBone Wedge

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

On-Brand Devices [restor3d Utility Wedge]

00840097503592Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 10 Degree
00840097503585Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 5 Degree
00840097503578Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 14mm Thickness, 0 Degree
00840097503561Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 10 Degree
00840097503554Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 5 Degree
00840097503547Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 0 Degree
00840097503530Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 10 Degree
00840097503523Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 5 Degree
00840097503516Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 10mm Thickness, 0 Degree
00840097503509Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 10 Degree
00840097503493Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 5 Degree
00840097503486Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 0 Degree
00840097503479Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 10 Degree
00840097503462Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 5 Degree
00840097503455Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 12mm Thickness, 0 Degree
00840097503448Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 10 Degree
00840097503431Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 5 Degree
00840097503424Titanium (Ti-6AL-4V) Subtalar Wedge, Left Foot, Large Footprint, 10mm Thickness, 0 Degree
00840097503417Titanium (Ti-6AL-4V) Subtalar Wedge, Right Foot, Small Footprint, 14mm Thickness, 10 Degree
00840097503400Titanium (Ti-6AL-4V) Subtalar Wedge, Right Foot, Small Footprint, 14mm Thickness, 5 Degree
00840097503394Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 14mm Thickness, 0 Degree
00840097503387Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 12mm Thickness,10 Degree
00840097503370Titanium (Ti-6AI-4V) Subtalar Wedge, Right foot, Small Footprint, 12mm Thickness, 5 Degree
00840097503363Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 12mm Thickness, 0 Degree
00840097503356Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 10 Degree
00840097503349Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 5 Degree
00840097503332Titanium (Ti-6AI-4V) Subtalar Wedge, Right Foot, Small Footprint, 10mm Thickness, 0 Degree
00840097503325Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 10 Degree
00840097503318Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 5 Degree
00840097503301Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 14mm Thickness, 0 Degree
00840097503295Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 10 Degree
00840097503288Titanium (Ti-6AI-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 5 Degree
00840097503271Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 12mm Thickness, 0 Degree
00840097503264Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 10 Degree
00840097503257Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 5 Degree
00840097503240Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Small Footprint, 10mm Thickness, 0 Degree
00840097505046Ti Anatomic Evans Wedge, Large Footprint, 12mm Thickness
00840097505039Ti Anatomic Evans Wedge, Large Footprint, 10mm Thickness
00840097505022Ti Anatomic Evans Wedge, Large Footprint, 8mm Thickness
00840097505015Ti Anatomic Evans Wedge, Large Footprint, 6mm Thickness
00840097505008Ti Anatomic Evans Wedge, Medium Footprint, 12mm Thickness
00840097504995Ti Anatomic Evans Wedge, Medium Footprint, 10mm Thickness
00840097504988Ti Anatomic Evans Wedge, Medium Footprint, 8mm Thickness
00840097504971Ti Anatomic Evans Wedge, Medium Footprint, 6mm Thickness
00840097504964Ti Anatomic Evans Wedge, Small Footprint, 12mm Thickness
00840097504957Ti Anatomic Evans Wedge, Small Footprint, 10mm Thickness
00840097504940Ti Anatomic Evans Wedge, Small Footprint, 8mm Thickness
00840097504933Ti Anatomic Evans Wedge, Small Footprint, 6mm Thickness

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.