Sentry Lateral Plating System

GUDID 00190837016586

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837016586
• NIH Device Record Key: 0d8852ec-bad3-484c-b0c2-4e141555ff17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentry Lateral Plating System
• Version Model Number: 161-5-018
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837016586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093200

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190837016586]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-19

On-Brand Devices [Sentry Lateral Plating System]

• 00190837016777: 161-6560
• 00190837016760: 161-6555
• 00190837016753: 161-6550
• 00190837016746: 161-6545
• 00190837016739: 161-6540
• 00190837016722: 161-6535
• 00190837016715: 161-6530
• 00190837016708: 161-6525
• 00190837016692: 161-5560
• 00190837016685: 161-5555
• 00190837016678: 161-5550
• 00190837016661: 161-5545
• 00190837016654: 161-5540
• 00190837016647: 161-5535
• 00190837016630: 161-5530
• 00190837016623: 161-5525
• 00190837016616: 161-4-024
• 00190837016609: 161-4-022
• 00190837016593: 161-4-020
• 00190837016586: 161-5-018
• 00190837016579: 161-5-016
• 00190837030254: SENTRY 2 Set Screw
• 00190837030247: SENTRY 2 Screw, Variable Angle, 6.5mm x 60mm
• 00190837030230: SENTRY 2 Screw, Variable Angle, 6.5mm x 55mm
• 00190837030223: SENTRY 2 Screw, Variable Angle, 6.5mm x 50mm
• 00190837030216: SENTRY 2 Screw, Variable Angle, 6.5mm x 45mm
• 00190837030209: SENTRY 2 Screw, Variable Angle, 6.5mm x 40mm
• 00190837030193: SENTRY 2 Screw, Variable Angle, 6.5mm x 35mm
• 00190837030186: SENTRY 2 Screw, Variable Angle, 6.5mm x 30mm
• 00190837030179: SENTRY 2 Screw, Variable Angle, 6.5mm x 25mm
• 00190837030162: SENTRY 2 Screw, Variable Angle, 5.5mm x 60mm
• 00190837030155: SENTRY 2 Screw, Variable Angle, 5.5mm x 55mm
• 00190837030148: SENTRY 2 Screw, Variable Angle, 5.5mm x 50mm
• 00190837030131: SENTRY 2 Screw, Variable Angle, 5.5mm x 45mm
• 00190837030124: SENTRY 2 Screw, Variable Angle, 5.5mm x 40mm
• 00190837030117: SENTRY 2 Screw, Variable Angle, 5.5mm x 35mm
• 00190837030100: SENTRY 2 Screw, Variable Angle, 6.5mm x 25mm
• 00190837030094: SENTRY 2 Screw, Variable Angle, 5.5mm x 25mm
• 00190837030087: SENTRY 2 Lateral Plate 16mm
• 00190837030070: SENTRY 2 Lateral Plate 14mm
• 00190837030063: SENTRY 2 Lateral Plate 12mm
• 00190837030056: SENTRY 2 Lateral Plate 10mm
• 00190837030049: SENTRY 2 Lateral Plate 8mm