Centerline 176-055

GUDID 00190837105501

Centerline GX ø5.0mm Tap, Cannulated

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837105501
NIH Device Record Keyee04ec2a-2847-4101-966d-ecf5e9013389
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterline
Version Model Number176-055
Catalog Number176-055
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 Usefalse
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
GS100190837105501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837105501]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Centerline]

00190837089207T25 Polyaxial Screwdriver, Cannulated
001908370856434.75mm Rod Pusher
001908370854074.75mm Rod/Cross Connector Holder
00190837096205Tap Distractor
00190837094027Modular Extended Tab Tulip Head, 4.0mm-7.5mm
00190837094010Extended Tab Tulip Caddy
00190837085650Tap Distractor
001908370853915.5mm In Situ Rod Bender
001908370853845.5mm In Situ Rod Bender
00190837105549Centerline GX ø7.5mm Tap, Cannulated
00190837105532Centerline GX ø6.5mm Tap, Cannulated
00190837105525Centerline GX ø6.0mm Tap, Cannulated
00190837105518Centerline GX ø5.5mm Tap, Cannulated
00190837105501Centerline GX ø5.0mm Tap, Cannulated
00190837105495Centerline GX ø4.5mm Tap, Cannulated
00190837105488Centerline GX ø6.0mm Tap, Noncannulated
00190837102623T25 Polyaxial Screwdriver, Non-Cannulated, Power
00190837102616T25 Polyaxial Screwdriver, Cannulated, Power
00190837102609T25 Polyaxial Screwdriver, Non-Cannulated, Reduction
00190837102593T25 Polyaxial Screwdriver, Cannulated, Reduction

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