Universal Neuro III
Suboccipital Plate, T-Shape
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
19recalls on this code
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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112557 |
| Record published | 2017-12-17 |
| Record revised | 2025-06-09 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 92-00686 | Thickness: 0.6 Millimeter | 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 |
| Innovasis® Cranial System | Inno-Health Technology Co., Ltd. | 21 |
| 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 |
Showing 12 of 45. All products under Plate, Cranioplasty, Preformed, Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182425 | 2018-11-06 |
Recalls
19 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-03-29 | Class II | Under Investigation by firm | Mislabeled: Product labeled 56-90614 (90×90 Gold Mesh), was actually 56-90314 (90×90 Blue Mesh), may cause a delay in procedure | 63 units | |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
| 2018-06-22 | Class II | Package design/selection | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | 22,831 total | 2019-07-08 |
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.