Hinged Laminoplasty 174-808PM

GUDID 00190837103507

Neutral 8mm Parallel Plate, Midline Hinge

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837103507
NIH Device Record Key550eb674-de7e-408e-9412-d4557dd70ec0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHinged Laminoplasty
Version Model Number174-808PM
Catalog Number174-808PM
Company DUNS183641617
Company NameLife Spine, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837103507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837103507]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-12
Device Publish Date2019-11-04

On-Brand Devices [Hinged Laminoplasty]

00190837104474Installer
00190837104467Driver
0019083710445011mm Drill
001908371044439mm Drill
001908371044367mm Drill
001908371044295mm Drill
00190837104412Plate Holder
00190837104405Drill Guide
00190837104399Plate Bender/Cutter
001908371043829mm X 12mm Laminoplasty Spacer
001908371043759mm X 10mm Laminoplasty Spacer
001908371043689mm X 8mm Laminoplasty Spacer
001908371043519mm X 6mm Laminoplasty Spacer
001908371043449mm X 4mm Laminoplasty Spacer
00190837104337Laminoplasty Coupling Screw
001908371043207mm X 12mm Laminoplasty Spacer
001908371043137mm X 10mm Laminoplasty Spacer
001908371043067mm X 8mm Laminoplasty Spacer
001908371042907mm X 6mm Laminoplasty Spacer
001908371042837mm X 4mm Laminoplasty Spacer
001908371042765mm X 12mm Laminoplasty Spacer
001908371042695mm X 10mm Laminoplasty Spacer
001908371042525mm X 8mm Laminoplasty Spacer
001908371042455mm X 6mm Laminoplasty Spacer
001908371042385mm X 4mm Laminoplasty Spacer
00190837104221Retaining Laminoplasty Locking Screw, 3.0mm x 11mm
00190837104214Retaining Laminoplasty Locking Screw, 3.0mm x 9mm
00190837104207Retaining Laminoplasty Locking Screw, 3.0mm x 7mm
00190837104191Retaining Laminoplasty Locking Screw, 3.0mm x 5mm
00190837104184Retaining Laminoplasty Locking Screw, 2.4mm x 11mm
00190837104177Retaining Laminoplasty Locking Screw, 2.4mm x 9mm
00190837104160Retaining Laminoplasty Locking Screw, 2.4mm x 7mm
00190837104153Retaining Laminoplasty Locking Screw, 2.4mm x 5mm
00190837104146Bent 12mm Midline Plate, Hybrid Hinge
00190837104139Bent 12mm Parallel Plate, Parallel Hinge
00190837104122Bent 12mm Parallel Plate, Midline Hinge
00190837104115Bent 12mm Parallel Plate, Hybrid Hinge
00190837104108Bent 12mm Midline Plate, Parallel Hinge
00190837104092Bent 12mm Midline Plate, Midline Hinge
00190837104085Bent 10mm Midline Plate, Hybrid Hinge
00190837104078Bent 12mm Hybrid Plate, Parallel Hinge
00190837104061Bent 12mm Hybrid Plate, Midline Hinge
00190837104054Bent 12mm Hybrid Plate, Hybrid Hinge
00190837104047Bent 10mm Parallel Plate, Parallel Hinge
00190837104030Bent 10mm Parallel Plate, Midline Hinge
00190837104023Bent 10mm Parallel Plate, Hybrid Hinge
00190837104016Bent 10mm Midline Plate, Parallel Hinge
00190837104009Bent 10mm Midline Plate, Midline Hinge
00190837103996Bent 10mm Hybrid Plate, Parallel Hinge
00190837103989Bent 10mm Hybrid Plate, Midline Hinge

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