Resorb XG, Sterile
Mesh, Specialty, SUN Pattern, Partial Small Grid, Plla-PGA
3manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (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 |
| Quanzhou Apex Hygiene Products Co., Ltd. | Jinjiang | Fujian | Manufacturer | 8 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-03-23 |
| Record revised | 2023-09-18 (version 7) |
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 |
|---|---|---|
| 52-877-04-04 | 4 HOLE, 26 MM, T= 1.0 MM | In distribution |
| 52-875-04-04 | 4 HOLE, 21 MM, T=1.0 MM | In distribution |
| 52-810-14-04 | 126 X 11 MM, T=1.0 MM | In distribution |
| 52-810-52-04 | 51 X 51 MM, T=1.0 MM | In distribution |
| 52-812-24-04 | 5 HOLE, 22 MM DIA, T=1.0 MM | In distribution |
| 52-806-20-04 | 73 X 11 MM, T=0.6 MM | In distribution |
| 52-810-25-04 | 26 X 26 MM, T=1.0 MM | In distribution |
| 52-890-30-04 | 30 MM | In distribution |
| 52-810-31-04 | 106 X 31 MM, T=1.0 MM | In distribution |
| 52-808-13-04 | 126 X 126 MM, T=0.8 MM | In distribution |
| 52-803-13-04 | 126 X 126 MM, T=0.3 MM | In distribution |
| 52-810-50-04 | 51 X 51 MM, T=1.0 MM | In distribution |
| 52-814-02-04 | 101 X 101 MM, T=0.3 MM | In distribution |
| 52-851-00-04 | 251 X 16 MM, T=0.8 MM | In distribution |
| 52-810-40-04 | 4 HOLE, 40 MM, T=1.0 MM | In distribution |
| 52-806-22-04 | 22 HOLE, 111 MM, T=0.6 MM | In distribution |
| 52-806-08-04 | 8 HOLE, 41 MM, T=0.6 MM | In distribution |
| 52-806-10-04 | 10 HOLE, 51 MM, T=0.6 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 87 |
| Neuro Plating System | Osteonic Co., Ltd. | 55 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 40 |
| “2.0MM” System | Biomet Microfixation | 26 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 15 |
| CMF System | Biomet Microfixation | 14 |
| Fastener, Plate, Cranioplasty | Biomet Microfixation | 14 |
| AXS | Stryker Leibinger Gmbh & Co. KG | 14 |
| Raas Cranial Plating System | Alliance Partners, LLC | 12 |
| Thinflap System | Biomet Microfixation | 12 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 11 |
| NeuroPro® Low Profile | Kinamed, Inc. | 10 |
Showing 12 of 45. All products under Fastener, Plate, Cranioplasty
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.