Tornier Perform
CortiLoc™/PEGGED PERIPHERAL DRILL GUIDE
26manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | FZX |
| Device type | Guide, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-09 |
| Record revised | 2024-08-13 (version 3) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 2.5 to 29 mm; angle 0 to 10 °; length 100 to 220 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MWH622 | In distribution | |
| MWH683S | Size LARGE/EXTRA LARGE | In distribution |
| MWJ117 | In distribution | |
| MWH622S | In distribution | |
| MWE040 | Outer Diameter 6 mm | In distribution |
| MWE112 | Angle 5 ° | In distribution |
| MWH680S | Size SMALL/MEDIUM | In distribution |
| MWJ101 | Outer Diameter 25 mm | In distribution |
| IFX819 | In distribution | |
| IFX712 | In distribution | |
| MWJ102 | Outer Diameter 29 mm | In distribution |
| MWJ153 | Outer Diameter 6.5 mm | In distribution |
| MWJ154 | Outer Diameter 9.5 mm | In distribution |
| MWH687 | Size SMALL/MEDIUM | In distribution |
| MWJ105 | Size LARGE | In distribution |
| MWH682 | Size LARGE/X-LARGE | In distribution |
| MWH629 | In distribution | |
| MWE091 | Size: Large/X-Large | In distribution |
| IFX711 | In distribution | |
| MWH683 | Size LARGE/X-LARGE | In distribution |
| MWJ168 | Type: Half Wedge | In distribution |
| MWE096 | Size: Large/X-Large | In distribution |
| MWE090 | Size: Small/Medium | In distribution |
| MWE081 | Size: Small/Medium | In distribution |
| IFX809 | In distribution | |
| MWJ106 | Size EXTRA LARGE | In distribution |
| MWH608S | In distribution | |
| MWJ103 | Size SMALL | In distribution |
| MWJ124 | In distribution | |
| MWH681S | Size SMALL/MEDIUM | In distribution |
| MWH681 | Size SMALL/MEDIUM | In distribution |
| MWM200 | Length 100 mm | In distribution |
| MWH682S | Size LARGE/EXTRA LARGE | In distribution |
| MWM100 | Length 100 mm | In distribution |
| MWH750 | In distribution | |
| MWJ115 | Size 9.5 mm | In distribution |
| MWE095 | Size: Small/Medium | In distribution |
| MWH751 | In distribution | |
| MWJ169 | Type: Half Wedge | In distribution |
| MWE113 | Angle 10 ° | In distribution |
| MWJ159 | Size 4 mm | In distribution |
| MWH688 | Size LARGE/EXTRA LARGE | In distribution |
| MWH680 | Size SMALL/MEDIUM | In distribution |
| MWJ114 | Size 6.5 mm | In distribution |
| MWH629S | In distribution | |
| MWJ104 | Size MEDIUM | In distribution |
| MWE085 | In distribution | |
| MWE111 | Angle 0 ° | In distribution |
| MWE082 | Size: Large/X-Large | In distribution |
| MWJ152 | Outer Diameter 9.5 mm | In distribution |
| MWJ151 | Outer Diameter 6.5 mm | In distribution |
| MWJ160 | Outer Diameter 29 mm | In distribution |
| DWD017 | Length 220 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 2,141 |
| Guide, Surgical, Instrument | Synthes Gmbh | 727 |
| DJO Surgical | DJO, LLC | 284 |
| Apex Knee System | Omni Life Science, Inc. | 272 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 223 |
| Motoband CP | Crossroads Extremity Systems LLC | 221 |
| Advance® | Microport Orthopedics Inc. | 199 |
| NexGen® | Zimmer, Inc. | 194 |
| Evolution® | Microport Orthopedics Inc. | 173 |
| Innomed, Inc. | Innomed, Inc. | 172 |
| Newclip Instruments | Newclip Technics SAS | 144 |
| Guide, Surgical, Instrument | Zimmer, Inc. | 135 |
Showing 12 of 1,788. All products under Guide, Surgical, Instrument
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.