Simmetry 9005140

GUDID 00810142530002

SImmetry Implant 8.5mm X 40mm

Sivantage, Inc.

Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant Sacroiliac joint intra-articular arthrodesis implant

• Primary Device ID: 00810142530002
• NIH Device Record Key: 823c1366-14d8-4551-811f-73602e72bc27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simmetry
• Version Model Number: B
• Catalog Number: 9005140
• Company DUNS: 119049891
• Company Name: Sivantage, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net
• Phone: 1-855-622-9100
• Email: customerservice@sivantage.net

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810142530002 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

[00810142530002]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-07
• Device Publish Date: 2023-11-29