Resorb XG, Sterile
Mesh, Specialty, SUN Pattern, Partial Foil, Plla-PGA
2manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-03-23 |
| Record revised | 2023-09-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52-876-22-04 | 22 HOLE, 111 MM, T=1.0 MM | In distribution |
| 52-812-14-04 | 5 HOLE, 12 MM DIA, T=1.0 MM | In distribution |
| 52-810-12-04 | 126 X 126 MM, T=1.0 MM | In distribution |
| 52-806-51-04 | 51 X 51 MM, T=0.6 MM | In distribution |
| 52-849-00-04 | 246 X 11 MM, T=1.0 MM | In distribution |
| 52-810-11-04 | 126 X 11 MM, T=1.0 MM | In distribution |
| 52-806-50-04 | 51 X 51 MM, T=0.6 MM | In distribution |
| 52-808-11-04 | 126 X 11 MM, T=0.8 MM | In distribution |
| 52-810-53-04 | 51 X 51 MM, T=1.0 MM | In distribution |
| 52-890-06-04 | 6 HOLE, 23 MM, T=1.0 MM | In distribution |
| 52-803-50-04 | 51 X 51 MM, T=0.3 MM | In distribution |
| 52-814-12-04 | 126 X 126 MM, T=1.0 MM | In distribution |
| 52-810-13-04 | 126 X 126 MM, T=1.0 MM | In distribution |
| 52-806-25-04 | 26 X 26 MM, T=0.6 MM | In distribution |
| 52-808-22-04 | 22 HOLE, 111 MM, T=0.8 MM | In distribution |
| 52-814-01-04 | 101 X 101 MM, T=0.3 MM | In distribution |
| 52-808-50-04 | 51 X 51 MM, T=0.8 MM | In distribution |
| 52-806-40-04 | 4 HOLE, 40 MM, T=0.6 MM | In distribution |
| 52-810-27-04 | 104 X 29 MM, T=1.0 MM | In distribution |
| 52-810-51-04 | 51 X 31 MM, T=1.0MM | In distribution |
| 52-812-19-04 | 5 HOLE, 17 MM DIA, T=1.0 MM | In distribution |
| 52-808-55-04 | 51 X 51 MM, T=1.5 MM | In distribution |
| 52-890-40-04 | 40 MM | In distribution |
| 52-815-11-04 | 126 X 11 MM, T=1.5 MM | In distribution |
| 52-842-23-04 | 20 X 20 MM, T=0.3 MM | In distribution |
| 52-806-13-04 | 126 X 126 MM, T=0.6 MM | 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 |
| 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 |
|---|---|
| K121606 | 2013-01-17 |
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.