Sentry Lateral Plating System

GUDID 00190837016586

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837016586
NIH Device Record Key0d8852ec-bad3-484c-b0c2-4e141555ff17
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentry Lateral Plating System
Version Model Number161-5-018
Company DUNS183641617
Company NameLife Spine, Inc.
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 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
GS100190837016586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837016586]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-19

On-Brand Devices [Sentry Lateral Plating System]

00190837016777161-6560
00190837016760161-6555
00190837016753161-6550
00190837016746161-6545
00190837016739161-6540
00190837016722161-6535
00190837016715161-6530
00190837016708161-6525
00190837016692161-5560
00190837016685161-5555
00190837016678161-5550
00190837016661161-5545
00190837016654161-5540
00190837016647161-5535
00190837016630161-5530
00190837016623161-5525
00190837016616161-4-024
00190837016609161-4-022
00190837016593161-4-020
00190837016586161-5-018
00190837016579161-5-016
00190837030254SENTRY 2 Set Screw
00190837030247SENTRY 2 Screw, Variable Angle, 6.5mm x 60mm
00190837030230SENTRY 2 Screw, Variable Angle, 6.5mm x 55mm
00190837030223SENTRY 2 Screw, Variable Angle, 6.5mm x 50mm
00190837030216SENTRY 2 Screw, Variable Angle, 6.5mm x 45mm
00190837030209SENTRY 2 Screw, Variable Angle, 6.5mm x 40mm
00190837030193SENTRY 2 Screw, Variable Angle, 6.5mm x 35mm
00190837030186SENTRY 2 Screw, Variable Angle, 6.5mm x 30mm
00190837030179SENTRY 2 Screw, Variable Angle, 6.5mm x 25mm
00190837030162SENTRY 2 Screw, Variable Angle, 5.5mm x 60mm
00190837030155SENTRY 2 Screw, Variable Angle, 5.5mm x 55mm
00190837030148SENTRY 2 Screw, Variable Angle, 5.5mm x 50mm
00190837030131SENTRY 2 Screw, Variable Angle, 5.5mm x 45mm
00190837030124SENTRY 2 Screw, Variable Angle, 5.5mm x 40mm
00190837030117SENTRY 2 Screw, Variable Angle, 5.5mm x 35mm
00190837030100SENTRY 2 Screw, Variable Angle, 6.5mm x 25mm
00190837030094SENTRY 2 Screw, Variable Angle, 5.5mm x 25mm
00190837030087SENTRY 2 Lateral Plate 16mm
00190837030070SENTRY 2 Lateral Plate 14mm
00190837030063SENTRY 2 Lateral Plate 12mm
00190837030056SENTRY 2 Lateral Plate 10mm
00190837030049SENTRY 2 Lateral Plate 8mm

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