SacroFuse
FENESTRATED SCREW, CANNULATED, Ø12MM x 50MM, SACROFUSE
3manufacturers in China registered for this device type
117catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K150017 |
| Record published | 2018-06-08 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 8 to 14 mm; length 30 to 130 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-42402-40 | Outer Diameter 12 mm | In distribution |
| 13-42000 | In distribution | |
| 01-42403-50 | Length 50 mm | In distribution |
| 01-42202-50 | Outer Diameter 12 mm | In distribution |
| 01-42401-110 | Outer Diameter 10 mm | In distribution |
| 01-42202-35 | Outer Diameter 12 mm | In distribution |
| 01-42301-70 | Length 70 mm | In distribution |
| 01-42400-40 | Outer Diameter 8 mm | In distribution |
| 01-42403-70 | Length 70 mm | In distribution |
| 01-42201-65 | Length 65 mm | In distribution |
| 01-42404-100 | Length 100 mm | In distribution |
| 01-42201-45 | Outer Diameter 10 mm | In distribution |
| 01-42402-70 | Length 70 mm | In distribution |
| 01-42401-65 | Outer Diameter 10 mm | In distribution |
| 01-42400-55 | Length 55 mm | In distribution |
| 01-42201-60 | Length 60 mm | In distribution |
| 01-42404-70 | Outer Diameter 12 mm | In distribution |
| 01-42400-45 | Length 45 mm | In distribution |
| 01-42400-100 | Outer Diameter 8 mm | In distribution |
| 01-42401-120 | Length 120 mm | In distribution |
| 01-42405-60 | Outer Diameter 14 mm | In distribution |
| 01-42404-60 | Outer Diameter 12 mm | In distribution |
| 01-42300-70 | Length 70 mm | In distribution |
| 01-42403-65 | Length 65 mm | In distribution |
| 01-42404-40 | Outer Diameter 12 mm | In distribution |
| 01-42404-45 | Length 45 mm | In distribution |
| 01-42202-70 | Length 70 mm | In distribution |
| 01-42401-80 | Outer Diameter 10 mm | In distribution |
| 01-42302-55 | Outer Diameter 12 mm | In distribution |
| 01-42302-40 | Outer Diameter 12 mm | In distribution |
| 01-42404-80 | Outer Diameter 12 mm | In distribution |
| 01-42301-60 | Length 60 mm | In distribution |
| 01-42404-130 | Outer Diameter 12 mm | In distribution |
| 01-42301-35 | Length 35 mm | In distribution |
| 01-42403-40 | Outer Diameter 14 mm | In distribution |
| 01-42300-45 | Length 45 mm | In distribution |
| 01-42404-30 | Outer Diameter 12 mm | In distribution |
| 01-42202-60 | Outer Diameter 12 mm | In distribution |
| 01-42401-55 | Length 55 mm | In distribution |
| 01-42403-35 | Outer Diameter 14 mm | In distribution |
| 01-42302-60 | Outer Diameter 12 mm | In distribution |
| 01-42400-90 | Outer Diameter 8 mm | In distribution |
| 01-42404-50 | Outer Diameter 12 mm | In distribution |
| 01-42401-45 | Outer Diameter 10 mm | In distribution |
| 01-42400-60 | Outer Diameter 8 mm | In distribution |
| 01-42301-45 | Outer Diameter 10 mm | In distribution |
| 01-42400-35 | Length 35 mm | In distribution |
| 01-42401-130 | Outer Diameter 10 mm | In distribution |
| 01-42400-110 | Length 110 mm | In distribution |
| 01-42400-120 | Outer Diameter 8 mm | In distribution |
| 01-42201-30 | Length 30 mm | In distribution |
| 01-42402-45 | Outer Diameter 12 mm | In distribution |
| 01-42405-65 | Outer Diameter 14 mm | In distribution |
| 01-42400-130 | Length 130 mm | In distribution |
| 01-42400-65 | Length 65 mm | In distribution |
| 01-42405-55 | Outer Diameter 14 mm | In distribution |
| 01-42405-40 | Length 40 mm | In distribution |
| 01-42302-70 | Length 70 mm | In distribution |
| 01-42201-55 | Length 55 mm | In distribution |
| 01-42401-50 | Outer Diameter 10 mm | In distribution |
| 01-42300-60 | Length 60 mm | In distribution |
| 01-42404-90 | Length 90 mm | In distribution |
| 01-42404-55 | Length 55 mm | In distribution |
| 01-42300-55 | Outer Diameter 8 mm | In distribution |
| 01-42404-120 | Length 120 mm | In distribution |
| 01-42404-35 | Outer Diameter 12 mm | In distribution |
| 01-42202-30 | Length 30 mm | In distribution |
| 01-42402-35 | Length 35 mm | In distribution |
| 01-42301-55 | Length 55 mm | In distribution |
| 01-42300-65 | Outer Diameter 8 mm | In distribution |
| 01-42301-40 | Length 40 mm | In distribution |
| 01-42400-30 | Outer Diameter 8 mm | In distribution |
| 01-42400-70 | Outer Diameter 8 mm | In distribution |
| 01-42401-60 | Outer Diameter 10 mm | In distribution |
| 01-42402-60 | Outer Diameter 12 mm | In distribution |
| 01-42405-45 | Outer Diameter 14 mm | In distribution |
| 01-42404-65 | Length 65 mm | In distribution |
| 01-42401-30 | Outer Diameter 10 mm | In distribution |
| 01-42302-30 | Outer Diameter 12 mm | In distribution |
| 01-42302-35 | Outer Diameter 12 mm | In distribution |
| 01-42401-70 | Length 70 mm | In distribution |
| 01-42401-35 | Length 35 mm | In distribution |
| 01-42301-65 | Outer Diameter 10 mm | In distribution |
| 14-42002 | Outer Diameter 8 mm | In distribution |
| 01-42300-30 | Length 30 mm | In distribution |
| 01-42302-50 | Outer Diameter 12 mm | In distribution |
| 01-42405-50 | Length 50 mm | In distribution |
| 01-42402-55 | Outer Diameter 12 mm | In distribution |
| 01-42401-90 | Length 90 mm | In distribution |
| 01-42401-100 | Length 100 mm | In distribution |
| 01-42400-50 | Length 50 mm | In distribution |
| 01-42202-55 | Length 55 mm | In distribution |
| 01-42300-40 | Outer Diameter 8 mm | In distribution |
| 14-42003 | Outer Diameter 8 mm | In distribution |
| 01-42403-45 | Length 45 mm | In distribution |
| 01-42402-65 | Length 65 mm | In distribution |
| 01-42402-30 | Length 30 mm | In distribution |
| 01-42201-70 | Length 70 mm | In distribution |
| 01-42300-35 | Length 35 mm | In distribution |
| 01-42403-55 | Outer Diameter 14 mm | In distribution |
| 01-42202-40 | Outer Diameter 12 mm | In distribution |
| 01-42301-50 | Outer Diameter 10 mm | In distribution |
| 01-42302-45 | Outer Diameter 12 mm | In distribution |
| 01-42403-60 | Length 60 mm | In distribution |
| 01-42402-50 | Outer Diameter 12 mm | In distribution |
| 01-42201-40 | Length 40 mm | In distribution |
| 01-42400-80 | Length 80 mm | In distribution |
| 01-42401-40 | Length 40 mm | In distribution |
| 01-42300-50 | Outer Diameter 8 mm | In distribution |
| 01-42202-65 | Length 65 mm | In distribution |
| 01-42404-110 | Outer Diameter 12 mm | In distribution |
| 01-42201-35 | Outer Diameter 10 mm | In distribution |
| 01-42202-45 | Length 45 mm | In distribution |
| 01-42301-30 | Length 30 mm | In distribution |
| 01-42201-50 | Outer Diameter 10 mm | In distribution |
| 01-42302-65 | Length 65 mm | In distribution |
| 01-42405-70 | Length 70 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SI-LOK | Globus Medical, Inc. | 666 |
| Sacroiliac Joint Fusion System | Genesys Orthopedics Systems, LLC | 356 |
| SIros-X | Genesys Orthopedics Systems, LLC | 353 |
| PathLoc- SI Joint Fusion System | L&K Biomed Co., Ltd. | 229 |
| ARx SAI | Life Spine | 224 |
| Unity | Diomedical Co., Ltd. | 198 |
| SImmetry SI Joint Fusion System | Tenon Medical, Inc. | 173 |
| M.u.s.t. Sacral Iliac Screw and Pelvic Trauma System | Medacta International SA | 170 |
| Integrity-SI Fusion System | Lincotek Medical, LLC | 160 |
| Zespin SI Joint Fusion System | Aegis Spine | 150 |
| M.u.s.t. Sacral Iliac Screw System | Medacta International SA | 142 |
| Simmetry | Sivantage | 123 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150017 | 2015-04-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.