Simpact Sacroiliac Joint Compression Screw System

GUDID 00190837014148

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837014148
• NIH Device Record Key: a54dee50-6d55-4acc-8f80-a7b4bf489222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpact Sacroiliac Joint Compression Screw System
• Version Model Number: 152-12-415
• 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	00190837014148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141246

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

Moist Heat or Steam Sterilization

[00190837014148]

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: 2016-06-20

On-Brand Devices [Simpact Sacroiliac Joint Compression Screw System]

• 00190837014247: 152-12-770
• 00190837014230: 152-12-765
• 00190837014223: 152-12-760
• 00190837014216: 152-12-755
• 00190837014209: 152-12-750
• 00190837014193: 152-12-745
• 00190837014186: 152-12-740
• 00190837014179: 152-12-735
• 00190837014162: 152-12-730
• 00190837014155: 152-12-420
• 00190837014148: 152-12-415
• 00190837014131: 152-12-410
• 00190837014124: 152-08-160
• 00190837014117: 152-08-155
• 00190837014100: 152-08-150
• 00190837014094: 152-08-145
• 00190837014087: 152-08-140
• 00190837014070: 152-08-135