Compass International
Micrometer for measuring Carbon Fiber Pins on Head Frame
5manufacturers in China registered for this device type
40catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (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 |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Compass Intl., Inc., United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Premarket notification | Exempt |
| Record published | 2016-08-26 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REG-30-BC | In distribution | |
| REG-30-D | In distribution | |
| CYG-10-LPTP | In distribution | |
| PL-S-10 | In distribution | |
| REG-3002 | In distribution | |
| CYG-10-BTP | In distribution | |
| RU-300 | In distribution | |
| TP-10 | In distribution | |
| CW-20 | In distribution | |
| SST-10 | In distribution | |
| SLS-10 | In distribution | |
| CYG-14F-SCT10 | In distribution | |
| RU-150 | In distribution | |
| PL-EL-10 | In distribution | |
| CYG-5F-NPT10 | In distribution | |
| CYG-10-B2TP | In distribution | |
| CYG-10-PTP | In distribution | |
| SS-10 | In distribution | |
| CYG-9F-SCT10TP | In distribution | |
| CYG-10-STP | In distribution | |
| PL-L-10 | In distribution | |
| FP-10 | In distribution | |
| TP-30 | In distribution | |
| CYG-4F-CT10 | In distribution | |
| PL-ES-10 | In distribution | |
| SP-20 | In distribution | |
| CYG-9F-SCT10 | In distribution | |
| REG-30-BCENT | In distribution | |
| 63MRL | In distribution | |
| KCP-20 | In distribution | |
| CYG-SAP-10-2A | In distribution | |
| CYG-ERG-10D | In distribution | |
| PWR-TRAY | In distribution | |
| RFS-10 | In distribution | |
| VS-30 | In distribution | |
| SOFTWARE | In distribution | |
| CYG-4F-CT10TP | In distribution | |
| CYG-10-LSTP | In distribution | |
| CYG-5F-NPT10TP | In distribution | |
| REG-BCBAY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K964229 | 1997-08-19 |
| K935456 | 1995-10-13 |
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.