Xenix Medical Sacroiliac Fixation System

GUDID 00818345028371

SI Implant, 12mm x 80mm

Ht Medical, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00818345028371
• NIH Device Record Key: 836a7eea-dffe-4eda-a235-ec2e1c5646ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenix Medical Sacroiliac Fixation System
• Version Model Number: SS1-32-012080
• Company DUNS: 080386764
• Company Name: Ht Medical, LLC
• 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: 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: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com
• Phone: 888-594-8633
• Email: cs@xenixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345028371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231829

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [Xenix Medical Sacroiliac Fixation System]

• 00818345029095: Nav Awl Tip-Tap, 5mm
• 00818345029088: Graft Luer Adapter
• 00818345029071: Graft Plunger
• 00818345029064: Graft Funnel
• 00818345029040: SI Implant Inserter
• 00818345029033: SI Implant Nav Inserter
• 00818345029026: Nav SI Tap 12mm
• 00818345029019: Nav SI Tap 11mm
• 00818345029002: Nav SI Tap 10mm
• 00818345028999: Nav SI Tap 9mm
• 00818345028968: 11mm SI Tap
• 00818345028944: 9mm SI Tap
• 00818345028616: Nav Awl Tip-Tap, 7mm
• 00818345028449: SI Implant, 12mm x 115mm
• 00818345028432: SI Implant, 12mm x 110mm
• 00818345028425: SI Implant, 12mm x 105mm
• 00818345028418: SI Implant, 12mm x 100mm
• 00818345028401: SI Implant, 12mm x 95mm
• 00818345028395: SI Implant, 12mm x 90mm
• 00818345028388: SI Implant, 12mm x 85mm
• 00818345028371: SI Implant, 12mm x 80mm
• 00818345028364: SI Implant, 12mm x 75mm
• 00818345028357: SI Implant, 12mm x 70mm
• 00818345028340: SI Implant, 12mm x 65mm
• 00818345028333: SI Implant, 12mm x 60mm
• 00818345028326: SI Implant, 12mm x 55mm
• 00818345028319: SI Implant, 12mm x 50mm
• 00818345028302: SI Implant, 12mm x 45mm
• 00818345028296: SI Implant, 12mm x 40mm
• 00818345028289: SI Implant, 12mm x 35mm
• 00818345028272: SI Implant, 12mm x 30mm
• 00818345028265: SI Implant, 10.5mm x 115mm
• 00818345028258: SI Implant, 10.5mm x 110mm
• 00818345028241: SI Implant, 10.5mm x 105mm
• 00818345028234: SI Implant, 10.5mm x 100mm
• 00818345028227: SI Implant, 10.5mm x 95mm
• 00818345028210: SI Implant, 10.5mm x 90mm
• 00818345028203: SI Implant, 10.5mm x 85mm
• 00818345028173: 1/4" Sq to Tri-Flat Adapter
• 00818345028166: SI Implant, 10.5mm x 80mm
• 00818345028159: SI Implant, 10.5mm x 75mm
• 00818345028142: SI Implant, 10.5mm x 70mm
• 00818345028135: SI Implant, 10.5mm x 65mm
• 00818345028128: SI Implant, 10.5mm x 60mm
• 00818345028111: SI Implant, 10.5mm x 55mm
• 00818345028104: SI Implant, 10.5mm x 50mm
• 00818345028098: SI Implant, 10.5mm x 45mm
• 00818345028081: SI Implant, 10.5mm x 40mm
• 00818345028074: SI Implant, 10.5mm x 35mm
• 00818345028067: SI Implant, 10.5mm x 30mm