OsteoMed
1.6 System Bur Hole Groove Shunt Plate Sterile Qty 5
2manufacturers in China registered for this device type
103catalogue numbers in this listing
2recalls 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 | Osteomed, United States |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-04-07 |
| Record revised | 2022-09-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at controlled room temperature out of direct sunlight |
| Sizes | Length 3.5 to 94 mm; outer diameter 20 to 31 mm; length 1.46 to 3 in; outer diameter 1.6 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 218-0210 | Outer Diameter 20 mm | In distribution |
| 218-0234 | Length 58 mm | In distribution |
| 218-1604-SP-10 | Length 4 mm | In distribution |
| 218-0290-SP-01 | Length 90 mm | In distribution |
| 218-0230 | Length 29.9 mm | In distribution |
| 218-0202-SP-05 | Length 22 mm | In distribution |
| 114-1215 | Length 1.46 in | In distribution |
| 218-1603 | Length 3.5 mm | In distribution |
| 218-0223 | Length 91 mm | In distribution |
| 218-0214 | Length 29 mm | In distribution |
| 450-0646 | Length 3 in | In distribution |
| 218-0062-SP-05 | Outer Diameter 30 mm | In distribution |
| 114-1221 | Length 2.08 in | In distribution |
| 218-1605-SP-10 | Length 5 mm | In distribution |
| 220-0267 | In distribution | |
| 220-0644-78 | In distribution | |
| 218-0206 | Length 20 mm | In distribution |
| 218-0224 | Length 39 mm | In distribution |
| 218-0235 | Length 64 mm | In distribution |
| 220-0641-55 | In distribution | |
| 218-0206-SP-05 | Length 20 mm | In distribution |
| 218-0207-SP-05 | Length 14 mm | In distribution |
| 220-0266-02 | In distribution | |
| 218-0215 | Length 39 mm | In distribution |
| 218-0290 | Length 90 mm | In distribution |
| 218-1605 | Length 5 mm | In distribution |
| 218-0234-SP | Length 58 mm | In distribution |
| 218-0205 | Length 19 mm | In distribution |
| 218-0219 | Length 29 mm | In distribution |
| 218-0285-SP-01 | Length 79 mm | In distribution |
| 218-0233 | Length 65.4 mm | In distribution |
| 218-0097-SP-05 | Outer Diameter 26 mm | In distribution |
| 220-0644-67 | In distribution | |
| 218-0229 | Length 47.2 mm | In distribution |
| 218-0213-SP-05 | Outer Diameter 27 mm | In distribution |
| 218-0069-SP-05 | Outer Diameter 26 mm | In distribution |
| 218-0225 | Length 73 mm | In distribution |
| 220-0268 | In distribution | |
| 218-0201-SP-05 | Length 17 mm | In distribution |
| 220-0274 | In distribution | |
| 218-0204 | Length 73 mm | In distribution |
| 218-0226 | Length 56 mm | In distribution |
| 218-0201 | Length 17 mm | In distribution |
| 220-0217 | Length 1.71 in | In distribution |
| 220-0267-02 | In distribution | |
| 218-0227 | Length 94 mm | In distribution |
| 218-0214-SP-02 | Length 29 mm | In distribution |
| 218-0235-SP | Length 64 mm | In distribution |
| 220-0644-56 | In distribution | |
| 218-0217-SP-05 | Length 19 mm | In distribution |
| 218-0209 | Length 26 mm | In distribution |
| 218-0203 | Length 19 mm | In distribution |
| 218-0221 | Length 50 mm | In distribution |
| 218-0208-SP-05 | Length 19 mm | In distribution |
| 218-0234-SP-02 | Length 58 mm | In distribution |
| 218-0204-SP-05 | Length 73 mm | In distribution |
| 450-0647 | In distribution | |
| 218-0209-SP-05 | Length 26 mm | In distribution |
| 218-0232 | Length 56.2 mm | In distribution |
| 218-0231 | Length 46.7 mm | In distribution |
| 220-0261 | In distribution | |
| 218-0059-SP-02 | Length 18 mm | In distribution |
| 114-1615 | Length 1.46 in | In distribution |
| 220-0641-56 | In distribution | |
| 218-0220 | Length 40 mm | In distribution |
| 222-0266 | In distribution | |
| 220-0271 | In distribution | |
| 218-0211-SP-05 | Outer Diameter 27 mm | In distribution |
| 218-0060-SP-02 | Length 25 mm | In distribution |
| 218-0216 | Length 50 mm | In distribution |
| 450-0648 | In distribution | |
| 218-0205-SP-05 | Length 19 mm | In distribution |
| 218-0215-SP-02 | Length 39 mm | In distribution |
| 114-1621 | Length 2.08 in | In distribution |
| 218-0207 | Length 14 mm | In distribution |
| 218-0203-SP-05 | Length 19 mm | In distribution |
| 218-0208 | Length 19 mm | In distribution |
| 220-0270 | In distribution | |
| 220-0267-03 | In distribution | |
| 218-0061-SP-05 | Outer Diameter 26 mm | In distribution |
| 220-1621 | Length 61.98 mm | In distribution |
| 220-0644-57 | In distribution | |
| 220-0265 | In distribution | |
| 218-0210-SP-05 | Outer Diameter 20 mm | In distribution |
| 220-0263 | In distribution | |
| 218-0236 | Outer Diameter 1.6 in | In distribution |
| 220-0262 | In distribution | |
| 218-0216-SP-02 | Length 50 mm | In distribution |
| 218-0218 | Outer Diameter 23 mm | In distribution |
| 218-0212 | Outer Diameter 31 mm | In distribution |
| 218-0202 | Length 22 mm | In distribution |
| 218-0211 | Outer Diameter 27 mm | In distribution |
| 220-0266 | In distribution | |
| 220-0267-01 | In distribution | |
| 220-0644-77 | In distribution | |
| 218-0235-SP-02 | Length 64 mm | In distribution |
| 218-0228 | Outer Diameter 27 mm | In distribution |
| 218-0212-SP-02 | Outer Diameter 31 mm | In distribution |
| 218-0213 | Outer Diameter 27 mm | In distribution |
| 218-0217 | Length 19 mm | In distribution |
| 218-0285 | Length 79 mm | In distribution |
| 218-1604 | Length 4 mm | In distribution |
| 218-1606 | Length 6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| “1.0MM” System | Biomet Microfixation | 10 |
Showing 12 of 45. All products under Plate, Cranioplasty, Preformed, Alterable
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Osteomed | UDI-DI | 2023-05-31 | Class II | Nonconforming Material/Component | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| Osteomed | UDI-DI | 2023-05-31 | Class II | Nonconforming Material/Component | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
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.