Positioner, Socket
5 catalogue numbers from 6611-10, listed by Zimmer, Inc., United States, under Positioner, Socket. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KIL |
| Device type | Positioner, Socket |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Packaging | Pack of 75 |
| Distribution end date | 2017-05-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6611-10 | In distribution | ||
| 4329-02 | In distribution | ||
| 4333-02 | In distribution | ||
| 5049-13 | 6 | In distribution | |
| 6611-86-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 320 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 34 |
| Diplomat | Signus Medizintechnik Gmbh | 15 |
| Monopoly | Signus Medizintechnik Gmbh | 6 |
| endophix | Suzhou Endophix Co., Ltd. | 4 |
| Sterile Spine Pedicle Screw System | Wishbone Medical Inc. | 2 |
| Screw Head Positioner | Indius Medical Technologies PVT. Ltd. | 2 |
| Trilogy® | Zimmer, Inc. | 2 |
| External Fix | Smith & Nephew, Inc. | 2 |
| Positioner Guide | Abanza Tecnomed SL. | 1 |
| Cannulated Pedicle Marker | Captiva Spine, Inc. | 1 |
| Vanguard | Zimmer, Inc. | 1 |
Showing 12 of 33. All products under Positioner, Socket
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.