Simpact Custom 2019-0085

GUDID 00190837096212

Adjustable Parallel Pin Offset Guide

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837096212
• NIH Device Record Key: 10090f01-4d7a-4e63-a275-9707d123912e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpact Custom
• Version Model Number: 2019-0085
• Catalog Number: 2019-0085
• 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	00190837096212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180749

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[00190837096212]

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

Devices Manufactured by Life Spine, Inc.

• 00190837169428 - TruLift 1-Hole Plate: 2024-03-28
• 00190837147327 - ProLift Lateral: 2024-03-21
• 00190837171674 - ProLift Lateral: 2024-03-21
• 00190837138974 - ProLift: 2024-02-08
• 00190837169411 - TruLift: 2024-02-02
• 00190837116248 - Aileron: 2023-11-16
• 00190837168322 - ARx: 2023-11-16
• 00190837135393 - ARx: 2023-10-16