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SUSTAIN-RT Titanium Spacer, 10x30mm, 15mm, 15°
1manufacturer
65catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | PHM |
| Device type | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K181357 |
| Record published | 2019-06-27 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Height 6 to 17 mm; width 8 to 10 mm; length 22 to 30 mm; angle 2 to 22 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3145.5356 | Height 16 mm | In distribution |
| 3145.5355 | Width 10 mm | In distribution |
| 3145.4211 | Width 8 mm | In distribution |
| 3145.5354 | Angle 21 ° | In distribution |
| 3145.4109 | Height 9 mm | In distribution |
| 3145.4157 | Height 17 mm | In distribution |
| 1145.6255 | Angle 15 ° | In distribution |
| 1145.6110 | Length 30 mm | In distribution |
| 3145.6153 | Angle 8 ° | In distribution |
| 3145.6256 | Angle 15 ° | In distribution |
| 1145.6257 | Length 30 mm | In distribution |
| 3145.6356 | Width 10 mm | In distribution |
| 3145.4257 | Height 17 mm | In distribution |
| 1145.4109 | Length 22 mm | In distribution |
| 3145.4006 | Width 8 mm | In distribution |
| 1145.6132 | Height 12 mm | In distribution |
| 3145.6109 | Angle 6 ° | In distribution |
| 1145.6007 | Angle 2 ° | In distribution |
| 1145.5232 | Angle 15 ° | In distribution |
| 1145.4255 | Angle 15 ° | In distribution |
| 3145.5157 | Angle 8 ° | In distribution |
| 1145.6356 | Length 30 mm | In distribution |
| 3145.5255 | Width 10 mm | In distribution |
| 6145.1004 | In distribution | |
| 1145.6154 | Angle 8 ° | In distribution |
| 3145.6008 | Angle 4 ° | In distribution |
| 1145.4007 | Width 8 mm | In distribution |
| 1145.5153 | Width 10 mm | In distribution |
| 3145.5007 | Angle 2 ° | In distribution |
| 3145.4110 | Width 8 mm | In distribution |
| 1145.4155 | Height 15 mm | In distribution |
| 3145.5211 | Length 26 mm | In distribution |
| 1145.4210 | Height 10 mm | In distribution |
| 1145.4355 | Height 15 mm | In distribution |
| 1145.4254 | Angle 15 ° | In distribution |
| 3145.6155 | Length 30 mm | In distribution |
| 1145.5357 | Width 10 mm | In distribution |
| 1145.4356 | Length 22 mm | In distribution |
| 3145.6257 | Height 17 mm | In distribution |
| 3145.6355 | Width 10 mm | In distribution |
| 1145.5253 | Width 10 mm | In distribution |
| 3145.4355 | Height 15 mm | In distribution |
| 1145.4353 | Height 13 mm | In distribution |
| 3145.5110 | Width 8 mm | In distribution |
| 3145.4156 | Height 16 mm | In distribution |
| 1145.6006 | Width 8 mm | In distribution |
| 1145.4357 | Width 10 mm | In distribution |
| 3145.6156 | Length 30 mm | In distribution |
| 1145.4354 | Height 14 mm | In distribution |
| 1145.6357 | Height 17 mm | In distribution |
| 3145.4356 | Height 16 mm | In distribution |
| 3145.4232 | Width 9 mm | In distribution |
| 1145.5257 | Height 17 mm | In distribution |
| 1145.6008 | Angle 4 ° | In distribution |
| 1145.4154 | Angle 8 ° | In distribution |
| 1145.5111 | Length 26 mm | In distribution |
| 3145.4332 | Length 22 mm | In distribution |
| 6145.1001 | In distribution | |
| 3145.6255 | Angle 15 ° | In distribution |
| 3145.5253 | Angle 15 ° | In distribution |
| 1145.6111 | Angle 8 ° | In distribution |
| 1145.6254 | Width 10 mm | In distribution |
| 1145.6156 | Height 16 mm | In distribution |
| 1145.6355 | Angle 20 ° | In distribution |
| 1145.4157 | Length 22 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 2,299 |
| IdentiTi | Alphatec Spine, Inc. | 940 |
| Solar™ Interbody Fusion System | Degen Medical | 805 |
| Transcend Nanotec | Alphatec Spine, Inc. | 466 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 459 |
| E3D-A Interbody System | Evolution Spine, LLC | 308 |
| Battalion | Alphatec Spine, Inc. | 241 |
| Reef L | Seaspine Orthopedics Corporation | 207 |
| IdentiTi II | Alphatec Spine, Inc. | 163 |
| Modulus | Nuvasive, Inc. | 158 |
| Hedron | Globus Medical, Inc. | 156 |
| Roccia | Silony Medical Gmbh | 133 |
Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic
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.