Panels › Orthopedic › Product code OUR · Class 2
Sacroiliac Joint Fixation
Regulation 888.3040
7510(k)s in 12 months (133 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OUR
| Company | 510(k)s | Recalls |
|---|---|---|
| SI-BONE, Inc. | 27 | 1 |
| SurGenTec, LLC | 8 | 0 |
| Zyga Technology, Inc. | 6 | 0 |
| Life Spine, Inc. | 5 | 0 |
| Orthofix, Inc. | 5 | 0 |
| L&K BIOMED Co., Ltd. | 4 | 0 |
| Tenon Medical | 4 | 0 |
| Aegis Spine | 3 | 0 |
| Camber Spine Technologies | 3 | 0 |
| Cutting Edge Spine, LLC | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | SI-BONE, Inc. iFuse TORQ Implant System
Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) Open, Classified |
OUR | K203247 |
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: FIREBIRD" SI Fusion System
Product Name: FIREBIRD" SI Fusion System
Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw;
18-1030SP 11mm X 30mm FIREBIRD SI Screw;
18-1035SP 11mm X Open, Classified |
OUR | K200696 |
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