Universal Neuro 3
Straight Plate, 12mm Bar, with Tab
2manufacturers in China registered for this device type
35catalogue numbers in this listing
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 | 2015-06-16 |
| Record revised | 2025-06-09 (version 8) |
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 |
|---|---|---|
| 53-00324 | Thickness: 0.3 Millimeter | In distribution |
| 92-34228 | Thickness: 0.4 Millimeter | In distribution |
| 53-36212 | Number of Screw Holes: 2.0 Holes | In distribution |
| 92-00666 | Diameter: 5.7 Centimeter | In distribution |
| 92-36212 | Bar Length: 10.0 Millimeter | In distribution |
| 53-34216 | Thickness: 0.4 Millimeter | In distribution |
| 53-34630 | Number of Screw Holes: 4.0 Holes | In distribution |
| 92-00692 | Diameter: 4.1 Centimeter | In distribution |
| 53-00382 | Thickness: 0.3 Millimeter | In distribution |
| 53-34804 | Number of Screw Holes: 8.0 Holes | In distribution |
| 53-34230 | Number of Screw Holes: 4.0 Holes | In distribution |
| 53-34300 | Thickness: 0.4 Millimeter | In distribution |
| 92-00342 | Thickness: 0.3 Millimeter | In distribution |
| 92-34112 | Bar Length: 12.0 Millimeter | In distribution |
| 53-00346 | Thickness: 0.3 Millimeter | In distribution |
| 92-34612 | Thickness: 0.4 Millimeter | In distribution |
| 53-00362 | Thickness: 0.3 Millimeter | In distribution |
| 53-34608 | Thickness: 0.4 Millimeter | In distribution |
| 92-34012 | Thickness: 0.4 Millimeter | In distribution |
| 53-34622 | Number of Screw Holes: 6.0 Holes | In distribution |
| 53-34240 | Thickness: 0.4 Millimeter | In distribution |
| 92-34622 | Number of Screw Holes: 6.0 Holes | In distribution |
| 92-34633 | Thickness: 0.4 Millimeter | In distribution |
| 92-34016 | Number of Screw Holes: 6.0 Holes | In distribution |
| 53-00486 | Thickness: 0.4 Millimeter | In distribution |
| 53-34612 | Thickness: 0.4 Millimeter | In distribution |
| 53-34228 | Number of Screw Holes: 4.0 Holes | In distribution |
| 53-34212 | Number of Screw Holes: 2.0 Holes | In distribution |
| 53-34164 | Thickness: 0.4 Millimeter | In distribution |
| 92-34632 | Number of Screw Holes: 6.0 Holes | In distribution |
| 92-00486 | Thickness: 0.6 Millimeter | In distribution |
| 53-34406 | Bar Length: 6.0 Millimeter | In distribution |
| 53-00342 | Thickness: 0.3 Millimeter | In distribution |
| 53-00466 | Thickness: 0.4 Millimeter | In distribution |
| 92-00322 | Thickness: 0.3 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 |
| 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 |
| “1.0MM” System | Biomet Microfixation | 10 |
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.