Ifuse Implant System
76 catalogue numbers from 7075-90, listed by SI-Bone, Inc., United States, under Sacroiliac Joint Fixation. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
76catalogue numbers in this listing
27510(k) clearances naming this product code
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 | SI-Bone, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-08-21 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 30 to 90 mm; outer diameter 4 to 10.75 mm; width 7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7075-90 | Length 75 mm | In distribution |
| 4060-90 | Length 60 mm | In distribution |
| 4055-90 | Length 55 mm | In distribution |
| 7045M-90 | Length 45 mm | In distribution |
| 107585-90 | Length 85 mm | In distribution |
| 4085-90 | Length 85 mm | In distribution |
| 7555-90 | Outer Diameter 7.5 mm | In distribution |
| 4075-90 | Length 75 mm | In distribution |
| 7050M-100 | Length 50 mm | In distribution |
| 7070M-100 | Length 70 mm | In distribution |
| 7065M-100 | Length 65 mm | In distribution |
| 107545-90 | Length 45 mm | In distribution |
| 7085-90 | Length 85 mm | In distribution |
| 7040M-90 | Length 40 mm | In distribution |
| 7050-90 | Length 50 mm | In distribution |
| 7085M-90 | Outer Diameter 7.0 mm | In distribution |
| 107555-90 | Outer Diameter 10.75 mm | In distribution |
| 7080-90 | Length 80 mm | In distribution |
| 4065-90 | Length 65 mm | In distribution |
| 7040-90 | Length 40 mm | In distribution |
| 7060M-90 | Length 60 mm | In distribution |
| 4050-90 | Length 50 mm | In distribution |
| 7045M-100 | Length 45 mm | In distribution |
| 107590-90 | Outer Diameter 10.75 mm | In distribution |
| 4030-90 | Length 30 mm | In distribution |
| 107550-90 | Length 50 mm | In distribution |
| 107540-90 | Outer Diameter 10.75 mm | In distribution |
| 4090-90 | Length 90 mm | In distribution |
| 7545-90 | Outer Diameter 7.5 mm | In distribution |
| 7035M-100 | Length 35 mm | In distribution |
| 7530-90 | Length 30 mm | In distribution |
| 7065-90 | Length 65 mm | In distribution |
| 7075M-100 | Length 75 mm | In distribution |
| 7060M-100 | Length 60 mm | In distribution |
| 7085M-100 | Length 85 mm | In distribution |
| 7575-90 | Outer Diameter 7.5 mm | In distribution |
| 7580-90 | Length 80 mm | In distribution |
| 7080M-90 | Length 80 mm | In distribution |
| 7540-90 | Length 40 mm | In distribution |
| 7565-90 | Outer Diameter 7.5 mm | In distribution |
| 107530-90 | Outer Diameter 10.75 mm | In distribution |
| 4035-90 | Length 35 mm | In distribution |
| 7090-90 | Length 90 mm | In distribution |
| 107580-90 | Outer Diameter 10.75 mm | In distribution |
| 7080M-100 | Outer Diameter 7.0 mm | In distribution |
| 7070-90 | Length 70 mm | In distribution |
| 7050M-90 | Length 50 mm | In distribution |
| 7570-90 | Length 70 mm | In distribution |
| 107535-90 | Length 35 mm | In distribution |
| 4080-90 | Length 80 mm | In distribution |
| 4070-90 | Length 70 mm | In distribution |
| 7035-90 | Length 35 mm | In distribution |
| 7590-90 | Length 90 mm | In distribution |
| 7560-90 | Length 60 mm | In distribution |
| 7075M-90 | Outer Diameter 7.0 mm | In distribution |
| 7040M-100 | Length 40 mm | In distribution |
| 7550-90 | Length 50 mm | In distribution |
| 7030-90 | Length 30 mm | In distribution |
| 7585-90 | Outer Diameter 7.5 mm | In distribution |
| 107560-90 | Outer Diameter 10.75 mm | In distribution |
| 7055M-90 | Length 55 mm | In distribution |
| 7065M-90 | Length 65 mm | In distribution |
| 7090M-100 | Outer Diameter 7.0 mm | In distribution |
| 107575-90 | Length 75 mm | In distribution |
| 107570-90 | Outer Diameter 10.75 mm | In distribution |
| 107565-90 | Length 65 mm | In distribution |
| 7045-90 | Length 45 mm | In distribution |
| 7090M-90 | Length 90 mm | In distribution |
| 7035M-90 | Length 35 mm | In distribution |
| 7055-90 | Length 55 mm | In distribution |
| 7535-90 | Outer Diameter 7.5 mm | In distribution |
| 7060-90 | Length 60 mm | In distribution |
| 4045-90 | Length 45 mm | In distribution |
| 4040-90 | Length 40 mm | In distribution |
| 7070M-90 | Length 70 mm | In distribution |
| 7055M-100 | Length 55 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 |
|---|---|
| K253488 | 2026-02-11 |
| K253094 | 2025-10-09 |
| K241504 | 2024-08-19 |
| K241574 | 2024-07-02 |
| K233508 | 2024-01-26 |
| K231689 | 2023-06-30 |
| K222774 | 2022-12-22 |
| K222605 | 2022-09-29 |
| K213667 | 2022-06-10 |
| K220195 | 2022-05-26 |
| K203247 | 2021-02-25 |
| K193524 | 2020-03-31 |
| K190230 | 2019-04-03 |
| K182983 | 2018-11-27 |
| K162733 | 2017-03-10 |
| K160652 | 2016-06-03 |
| K152681 | 2016-03-01 |
| K151718 | 2015-10-29 |
| K150875 | 2015-07-22 |
| K150714 | 2015-04-17 |
| K141049 | 2014-07-23 |
| K131405 | 2013-10-16 |
| K123850 | 2013-04-01 |
| K122074 | 2012-10-12 |
| K110838 | 2011-04-21 |
| K092375 | 2009-09-04 |
| K080398 | 2008-11-26 |
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.