Innovasis® Cranial System
21 catalogue numbers from C2ST16102, listed by Inno-Health Technology Co., Ltd., Taiwan, under Plate, Cranioplasty, Preformed, Alterable. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
Record
| Listed by | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2014-12-29 |
| Record revised | 2026-02-12 (version 6) |
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, serial number |
| Sizes | Length 3 to 5 mm; outer diameter 1.6 to 1.9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C2ST16102 | In distribution | |
| C2ST16002 | In distribution | |
| BTA-100 | In distribution | |
| C2BR16156 | 15mm Diameter | In distribution |
| C2BR16226 | 22mm Diameter | In distribution |
| C5SD16003 | Length 3 mm | In distribution |
| C2ST16012 | In distribution | |
| LS-270 | In distribution | |
| C2ST16006 | In distribution | |
| C2BR16225 | 22mm Diameter | In distribution |
| LS-269 | In distribution | |
| C2DY16006 | In distribution | |
| C5SS19004 | Length 4 mm | In distribution |
| LS-267 | In distribution | |
| C3DM06100 | 0.6mm x 100mm | In distribution |
| C2SQ16004 | In distribution | |
| LS-268 | In distribution | |
| C5SD16005 | Length 5 mm | In distribution |
| LS-266 | In distribution | |
| C5SD16004 | Length 4 mm | In distribution |
| C2BR16155 | 15mm Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 103 |
| Plate, Cranioplasty, Preformed, Alterable | Stryker Leibinger Gmbh & Co. KG | 93 |
| 1.5MM System | Biomet Microfixation | 72 |
| Customized Skull Implant (CSI) | Kelyniam Global Inc. | 49 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 35 |
| 2.0MM System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 26 |
| Plate, Cranioplasty, Preformed, Alterable | Biomet Microfixation | 22 |
| NeuroPro® Low Profile | Kinamed, Inc. | 16 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 14 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
Showing 12 of 45. All products under Plate, Cranioplasty, Preformed, Alterable
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.