Gruve Anterior Cervical Plate System 113-119

GUDID 00190837065058

4.0mm Cervical FT Tap

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837065058
• NIH Device Record Key: bd159bad-d7d2-4b5b-8a8b-554c46b8a23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gruve Anterior Cervical Plate System
• Version Model Number: 113-119
• Catalog Number: 113-119
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	00190837065058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152282

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

[00190837065058]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Gruve Anterior Cervical Plate System]

• 00190837017446: 1682-052
• 00190837017439: 1682-050
• 00190837017422: 1682-048
• 00190837017415: 1682-046
• 00190837017408: 1682-044
• 00190837017392: 1682-042
• 00190837017385: 1682-040
• 00190837017378: 1682-038
• 00190837017361: 1682-036
• 00190837017354: 1682-034
• 00190837017347: 1681-036
• 00190837017330: 1681-034
• 00190837017323: 1681-032
• 00190837017316: 1681-030
• 00190837017309: 1681-028
• 00190837017293: 1681-026
• 00190837017286: 1681-024
• 00190837017279: 1681-022
• 00190837017262: 1681-020
• 00190837004071: 1583-067
• 00190837004064: 1583-064
• 00190837004057: 1583-061
• 00190837004040: 1583-058
• 00190837004033: 1583-055
• 00190837004026: 1583-052
• 00190837004019: 1582-046
• 00190837004002: 1582-044
• 00190837003999: 1582-042
• 00190837003982: 1582-040
• 00190837003975: 1582-038
• 00190837003968: 1582-036
• 00190837003951: 1581-028
• 00190837003944: 1581-026
• 00190837003937: 1581-024
• 00190837003920: 1581-022
• 00190837003913: 153-018
• 00190837003906: 153-016
• 00190837003890: 153-014
• 00190837003883: 153-012
• 00190837003876: 153-010
• 00190837003869: 152-018
• 00190837003852: 152-016
• 00190837003845: 152-014
• 00190837003838: 152-012
• 00190837003821: 152-010
• 00190837003814: 151-018
• 00190837003807: 151-016
• 00190837003791: 151-014
• 00190837003784: 151-012
• 00190837003777: 151-010