Integra® Compact Cranial Closure System
The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The…
The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
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 | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112812 |
| Record published | 2015-08-15 |
| Record revised | 2020-09-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Distribution end date | 2020-09-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRANCLOSIMP | 10.16 in L x 4.41 in W x 2.0 in H | Withdrawn |
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 |
| Resorb XG, Sterile | KLS-Martin L.P. | 18 |
| 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 |
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.