restor3d Lumbar Implant

GUDID 00840097507699

Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 15°

Restor3d, Inc.

Interspinous spinal fixation implant
Primary Device ID00840097507699
NIH Device Record Keyd18d48cb-512f-453a-8d32-abc5c6312558
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Lumbar Implant
Version Model Number1113-S1015
Company DUNS080819836
Company NameRestor3d, Inc.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097507699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-07
Device Publish Date2023-10-30

On-Brand Devices [restor3d Lumbar Implant]

00840097508412Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 18°
00840097508405Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 15°
00840097508399Lumbar ALIF Implant, Large Footprint, 30x38, 16 mm Height, 12°
00840097508368Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 18°
00840097508351Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 15°
00840097508344Lumbar ALIF Implant, Large Footprint, 30x38, 14 mm Height, 12°
00840097508313Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 18°
00840097508306Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 15°
00840097508290Lumbar ALIF Implant, Large Footprint, 30x38, 12 mm Height, 12°
00840097508269Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 18°
00840097508252Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 15°
00840097508245Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 12°
00840097508139Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 18°
00840097508122Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 15°
00840097508115Lumbar ALIF Implant, Medium Footprint, 28x35, 16 mm Height, 12°
00840097508085Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 18°
00840097508078Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 15°
00840097508061Lumbar ALIF Implant, Medium Footprint, 28x35, 14 mm Height, 12°
00840097508030Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 18°
00840097508023Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 15°
00840097508016Lumbar ALIF Implant, Medium Footprint, 28x35, 12 mm Height, 12°
00840097507989Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 18°
00840097507972Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 15°
00840097507965Lumbar ALIF Implant, Medium Footprint, 28x35, 10 mm Height, 12°
00840097507859Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 18°
00840097507842Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 15°
00840097507835Lumbar ALIF Implant, Small Footprint, 26x32, 16 mm Height, 12°
00840097507804Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 18°
00840097507798Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 15°
00840097507781Lumbar ALIF Implant, Small Footprint, 26x32, 14 mm Height, 12°
00840097507750Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 18°
00840097507743Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 15°
00840097507736Lumbar ALIF Implant, Small Footprint, 26x32, 12 mm Height, 12°
00840097507705Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 18°
00840097507699Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 15°
00840097507682Lumbar ALIF Implant, Small Footprint, 26x32, 10 mm Height, 12°

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