nuMIS Lumbar Plating System 27106-045

GUDID 00841193101149

6.75 x 45 mm Long Threaded, Ti Bolt

Cutting Edge Spine, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841193101149
NIH Device Record Keyd6eba82d-c41c-4e0b-9883-71f393f4a25b
Commercial Distribution StatusIn Commercial Distribution
Brand NamenuMIS Lumbar Plating System
Version Model Number27106-045
Catalog Number27106-045
Company DUNS069472647
Company NameCutting Edge Spine, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com

Device Dimensions

Length45 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100841193101149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841193101149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-30

On-Brand Devices [nuMIS Lumbar Plating System]

00841193120478nuMIS™ Drill Driver
00841193120461nuMIS™ Nut Driver
00841193103099nuMIS™ Long Hex Driver
008411931024986.75 x 30 mm Long Threaded, Ti Bolt
008411931024817.25 x 30 mm Long Threaded, Ti Bolt
008411931024747.75 x 30 mm Long Threaded, Ti Bolt
008411931024678.5 x 50mm Long Threaded, Ti Bolt
008411931024508.5 x 45mm Long Threaded, Ti Bolt
008411931024438.5 x 40 mm Long Threaded, Ti Bolt
008411931024368.5 x 35 mm Long Threaded, Ti Bolt
008411931024298.5 x 30 mm Long Threaded, Ti Bolt
008411931024125.75 x 35 mm Long Threaded, Ti Bolt
008411931016375.75 x 50 mm Long Threaded, Ti Bolt
008411931016205.75 x 45 mm Long Threaded, Ti Bolt
008411931016135.75 x 40 mm Long Threaded, Ti Bolt
008411931016067.75 x 50 mm Long Threaded, Ti Bolt
008411931015907.75 x 45 mm Long Threaded, Ti Bolt
008411931015837.75 x 40 mm Long Threaded, Ti Bolt
008411931015767.75 x 35 mm Long Threaded, Ti Bolt
008411931013547.25 x 50 mm Long Threaded, Ti Bolt
008411931013477.25 x 45 mm Long Threaded, Ti Bolt
008411931013307.25 x 40 mm Long Threaded, Ti Bolt
008411931013237.25 x 35 mm Long Threaded, Ti Bolt
00841193101316180 mm Ti Full Slot Plate
00841193101309160 mm Ti Full Slot Plate
00841193101293140 mm Ti Full Slot Plate
00841193101286130 mm Ti Full Slot Plate
00841193101279120 mm Ti Full Slot Plate
00841193101262110 mm Ti Full Slot Plate
00841193101255100 mm Ti Full Slot Plate
0084119310124890 mm Ti Full Slot Plate
0084119310123180 mm Ti Full Slot Plate
0084119310122470 mm Ti Full Slot Plate
0084119310121765 mm Ti Full Slot Plate
0084119310120060 mm Ti Full Slot Plate
0084119310119450 mm Ti Full Slot Plate
0084119310118740 mm Ti Full Slot Plate
00841193101170Ti Nut
00841193101163Ti Washer
008411931011566.75 x 50 mm Long Threaded, Ti Bolt
008411931011496.75 x 45 mm Long Threaded, Ti Bolt
008411931011326.75 x 40 mm Long Threaded, Ti Bolt
008411931011256.75 x 35 mm Long Threaded, Ti Bolt

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