SI-Restore® Sacroiliac Joint Fixation System

Sacroiliac Joint Fixation

Biofusion Medical

The following data is part of a premarket notification filed by Biofusion Medical with the FDA for Si-restore® Sacroiliac Joint Fixation System.

Pre-market Notification Details

• Device ID: K182919
• 510k Number: K182919
• Device Name: SI-Restore® Sacroiliac Joint Fixation System
• Classification: Sacroiliac Joint Fixation
• Applicant: Biofusion Medical 2503 Cedarview Drive Austin, TX 78704
• Contact: Rylan Reed
• Correspondent: Daniel Lanois; SurgOp Support 7512 Lancaster Gate Frisco, TX 75035
• Product Code: OUR
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-19
• Decision Date: 2019-01-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850073363683	K182919	000
00850073363249	K182919	000
00850073363256	K182919	000
00850073363263	K182919	000
00850073363270	K182919	000
00850073363287	K182919	000
00850073363294	K182919	000
00850073363300	K182919	000
00850073363317	K182919	000
00850073363324	K182919	000
00850073363331	K182919	000
00850073363232	K182919	000
00850073363225	K182919	000
00850073363669	K182919	000
00850073363676	K182919	000
00850073363140	K182919	000
00850073363157	K182919	000
00850073363164	K182919	000
00850073363171	K182919	000
00850073363188	K182919	000
00850073363195	K182919	000
00850073363201	K182919	000
00850073363218	K182919	000
00850073363348	K182919	000
00850073363355	K182919	000
00850073363362	K182919	000
00850073363034	K182919	000
00850073363041	K182919	000
00850073363058	K182919	000
00850073363065	K182919	000
00850073363072	K182919	000
00850073363089	K182919	000
00850073363096	K182919	000
00850073363102	K182919	000
00850073363119	K182919	000
00850073363126	K182919	000
00850073363027	K182919	000
00850073363010	K182919	000
00850073363379	K182919	000
00850073363386	K182919	000
00850073363393	K182919	000
00850073363409	K182919	000
00850073363416	K182919	000
00850073363423	K182919	000
00850073363430	K182919	000
00850073363621	K182919	000
00850073363638	K182919	000
00850073363003	K182919	000
00850073363133	K182919	000