SOLACE Sacroiliac Fixation System

GUDID 00818345028692

9mm SI Drill

Ht Medical, LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00818345028692
• NIH Device Record Key: ae9dece1-31bb-4280-82c1-6f0f232d0468
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLACE Sacroiliac Fixation System
• Version Model Number: SS1-A2-000109
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818345028692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231829

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

[00818345028692]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [SOLACE Sacroiliac Fixation System]

• 00818345029057: SI Mallet
• 00818345028982: Nav SI Tap 8mm
• 00818345028975: 12mm SI Tap
• 00818345028951: 10mm SI Tap
• 00818345028937: 8mm SI Tap
• 00818345028920: 12 Implant Guide to Pin Guide, 21mm
• 00818345028913: 12 Implant Guide to Pin Guide, 20mm
• 00818345028906: 12 Implant Guide to Pin Guide, 19mm
• 00818345028890: 12 Implant Guide to Pin Guide, 18mm
• 00818345028883: 12 Implant Guide to Pin Guide, 17mm
• 00818345028876: 12 Implant Guide to Pin Guide, 16mm
• 00818345028869: 12 Implant Guide to Pin Guide, 15mm
• 00818345028852: 10.5 Implant Guide to Pin Guide, 21mm
• 00818345028845: 10.5 Implant Guide to Pin Guide, 20mm
• 00818345028838: 10.5 Implant Guide to Pin Guide, 19mm
• 00818345028821: 10.5 Implant Guide to Pin Guide, 18mm
• 00818345028814: 10.5 Implant Guide to Pin Guide, 17mm
• 00818345028807: 10.5 Implant Guide to Pin Guide, 16mm
• 00818345028791: 10.5 Implant Guide to Pin Guide, 15mm
• 00818345028784: Pin to pin guide, 21mm
• 00818345028777: Pin to pin guide, 20mm
• 00818345028760: Pin to pin guide, 19mm
• 00818345028753: Pin to pin guide, 18mm
• 00818345028746: Pin to pin guide, 17mm
• 00818345028739: Pin to pin guide, 16mm
• 00818345028722: Pin to pin guide, 15mm
• 00818345028715: 11mm SI Drill
• 00818345028708: 10mm SI Drill
• 00818345028692: 9mm SI Drill
• 00818345028685: 8mm SI Drill
• 00818345028678: 7mm SI Drill
• 00818345028661: Pin Template
• 00818345028654: 12mm Drill Sleeve
• 00818345028647: Pin Depth Measurement
• 00818345028630: Guide Handle
• 00818345028623: Implant Guide Impactor
• 00818345028593: Ø12 Implant Guide, Spike Tip
• 00818345028586: Ø12 Implant Guide
• 00818345028579: Ø10.5 Implant Guide, Spiked Tip
• 00818345028562: Ø10.5 Implant Guide
• 00818345028555: Steinmann Pin Dilator, Ø12
• 00818345028548: Steinmann Pin Dilator, Ø10.5
• 00818345028531: Pin and Dilator Holder
• 00818345028524: Cannula Clean Out Pin
• 00818345028517: Transfer Pin
• 00818345028500: Steinmann Pin, 360mm, Diamond
• 00818345028494: Steinmann Pin, 360mm, Bevel
• 00818345028487: Steinmann Pin, 300mm, Diamond
• 00818345028470: Steinmann Pin, 300mm, Bevel
• 00818345028463: Steinmann Pin, 225mm, Diamond