Ambler Surgical
Universal drill guide, double-ended, for 3.2mm diameter drill bits, also for 4.5mm diameter cotrical screws and 4.5mm diameter malleolar shaft screws, can be used as a neutral/load drill…
Universal drill guide, double-ended, for 3.2mm diameter drill bits, also for 4.5mm diameter cotrical screws and 4.5mm diameter malleolar shaft screws, can be used as a neutral/load drill guide
26manufacturers in China registered for this device type
41catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | FZX |
| Device type | Guide, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tap sleeve | In distribution | |
| Schmieden ligature guide | In distribution | |
| Drill sleeve | In distribution | |
| Koenig ligature guide | In distribution | |
| Demel wire guide | In distribution | |
| Drill sleeve | In distribution | |
| Drill sleeve | In distribution | |
| Drill guide | In distribution | |
| Drill guide | In distribution | |
| House wire strut guide | In distribution | |
| Universal drill guide | In distribution | |
| Drill sleeve | In distribution | |
| Brunner guide probe | In distribution | |
| Drill sleeve | In distribution | |
| Drill sleeve | In distribution | |
| Kocher guide probe | In distribution | |
| Drill sleeve | In distribution | |
| Kirschner ligature guide | In distribution | |
| Drill sleeve | In distribution | |
| Payr ligature guide | In distribution | |
| Demel wire guide | In distribution | |
| Drill guide | In distribution | |
| Reese osteotome guide system set | In distribution | |
| Reese osteotome guide system | In distribution | |
| Reese osteotome guide system | In distribution | |
| Kocher guide probe | In distribution | |
| Ligature guide | In distribution | |
| Payr ligature guide | In distribution | |
| Pointed drill guide | In distribution | |
| Drill sleeve insert | In distribution | |
| Reese osteotome guide system | In distribution | |
| Tap sleeve | In distribution | |
| Drill sleeve | In distribution | |
| Drill sleeve | In distribution | |
| Demel wire guide | In distribution | |
| Koenig ligature guide | In distribution | |
| Universal drill guide | In distribution | |
| Koenig ligature guide | In distribution | |
| Reese osteotome guide system | In distribution | |
| Drill sleeve insert | In distribution | |
| Brunner guide probe | 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.