Pilot Spinal System 665-301

GUDID 00190837052034

NC Pilot Pedicle Screw 6.5mm x 30mm - 26mm

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837052034
• NIH Device Record Key: 7c8f8617-f2f4-4a10-9032-a60e737b4fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pilot Spinal System
• Version Model Number: 665-301
• Catalog Number: 665-301
• 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: 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	00190837052034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111729

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

Moist Heat or Steam Sterilization

[00190837052034]

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 [Pilot Spinal System]

• 00190837009663: 800-095
• 00190837009656: 8402-120
• 00190837009649: 8402-115
• 00190837009632: 8402-110
• 00190837009625: 8402-105
• 00190837009618: 8402-100
• 00190837009601: 8402-095
• 00190837009595: 8402-090
• 00190837009588: 8402-085
• 00190837009571: 8402-080
• 00190837009564: 8402-075
• 00190837009557: 8402-070
• 00190837009540: 8402-065
• 00190837009533: 8400-120
• 00190837009526: 8400-115
• 00190837009519: 8400-110
• 00190837009502: 8400-105
• 00190837009496: 8400-100
• 00190837009489: 8400-095
• 00190837009472: 8400-090
• 00190837009465: 8400-085
• 00190837009458: 8400-080
• 00190837009441: 8400-075
• 00190837009434: 8400-070
• 00190837009427: 8400-065
• 00190837009410: 8400-060
• 00190837009403: 8400-055
• 00190837009397: 8400-050
• 00190837009380: 8400-045
• 00190837009373: 8400-040
• 00190837009366: 1085-551
• 00190837009359: 1085-501
• 00190837009342: 1085-451
• 00190837009335: 1085-401
• 00190837009328: 1085-351
• 00190837009311: 1085-301
• 00190837009304: 8675-451
• 00190837009298: 8675-401
• 00190837009281: 8665-451
• 00190837009274: 8665-401
• 00190837009267: 8402-120B
• 00190837009250: 8402-115B
• 00190837009243: 8402-110B
• 00190837009236: 8402-105B
• 00190837009229: 8402-100B
• 00190837009212: 8402-095B
• 00190837009205: 8402-090B
• 00190837009199: 8402-085B
• 00190837009182: 8402-080B
• 00190837009175: 8402-075B