Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment
26.7 cm Irrigation Clip for 6 mm Diameter Tube. Use with LONG-G1, MEDIUM-G1, MIA16-G1, QD11-G1, QD11-S-G1, LONG, LONG-S, LONG-01, MEDIUM, MIA16, B-TURQ-L Attachments.
23manufacturers in China registered for this device type
226catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWE |
| Device type | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K043310 |
| Record published | 2016-12-31 |
| Record revised | 2026-06-30 (version 9) |
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 |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2026-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD311.432 | In distribution | |
| 05.001.226 | In distribution | |
| 03.617.912 | In distribution | |
| 05.001.220 | In distribution | |
| 05.001.203 | In distribution | |
| 511.30 | In distribution | |
| 03.025.083 | In distribution | |
| 03.000.307S | In distribution | |
| FILTER-II | In distribution | |
| 05.001.252 | In distribution | |
| 05.001.031 | In distribution | |
| 316.308 | In distribution | |
| 532.132 | In distribution | |
| 05.001.229 | In distribution | |
| SD03.505.005 | In distribution | |
| 310.02S | In distribution | |
| 03.000.150S | In distribution | |
| 310.37S | In distribution | |
| 532.026 | In distribution | |
| 05.001.074 | In distribution | |
| 03.000.329S | In distribution | |
| 03.000.021S | In distribution | |
| 05.001.210 | In distribution | |
| 511.414 | In distribution | |
| 03.000.335S | In distribution | |
| 310.60 | In distribution | |
| 532.021 | In distribution | |
| 03.025.126 | In distribution | |
| 530.795 | In distribution | |
| 310.16J | In distribution | |
| 310.11 | In distribution | |
| 03.000.084S | In distribution | |
| 310.11S | In distribution | |
| 532.103 | In distribution | |
| 03.000.233S | In distribution | |
| OIL-II | In distribution | |
| 05.001.022 | In distribution | |
| 03.000.002S | In distribution | |
| 05.001.218 | In distribution | |
| 03.000.322S | In distribution | |
| 03.000.054S | In distribution | |
| 03.168.005 | In distribution | |
| 03.000.361S | In distribution | |
| 310.29 | In distribution | |
| 519.51S | In distribution | |
| 05.001.205 | In distribution | |
| 310.161 | In distribution | |
| 03.000.118S | In distribution | |
| 03.617.914 | In distribution | |
| 519.50S | In distribution | |
| 310.36 | In distribution | |
| 310.65 | In distribution | |
| 03.617.941 | In distribution | |
| 03.000.365S | In distribution | |
| 05.001.254 | In distribution | |
| 03.000.003S | In distribution | |
| 05.001.212 | In distribution | |
| 05.001.059 | In distribution | |
| 03.000.055S | In distribution | |
| 316.290 | In distribution | |
| 05.001.035 | In distribution | |
| 310.143 | In distribution | |
| 05.001.101 | In distribution | |
| 03.000.092S | In distribution | |
| 05.001.216 | In distribution | |
| 03.000.227S | In distribution | |
| 03.000.000S | In distribution | |
| HOSECLIPS-G1 | In distribution | |
| 315.19S | In distribution | |
| 317.435 | In distribution | |
| 05.001.214 | In distribution | |
| 310.141S | In distribution | |
| 03.000.077S | In distribution | |
| 05.001.177 | In distribution | |
| 05.001.207 | In distribution | |
| 03.000.306S | In distribution | |
| 03.000.048S | In distribution | |
| 05.001.105 | In distribution | |
| 310.28S | In distribution | |
| 511.416 | In distribution | |
| 05.001.070 | In distribution | |
| 513.08 | In distribution | |
| IRR-TUBE | In distribution | |
| 532.023 | In distribution | |
| 519.51D | In distribution | |
| 03.000.303S | In distribution | |
| 310.90 | In distribution | |
| 03.025.084 | In distribution | |
| SD310.671 | In distribution | |
| 519.53S | In distribution | |
| 03.000.046S | In distribution | |
| 03.000.312S | In distribution | |
| 03.000.089S | In distribution | |
| 03.000.045S | In distribution | |
| 05.001.224 | In distribution | |
| 310.28 | In distribution | |
| 511.20 | In distribution | |
| 532.022 | In distribution | |
| 05.001.068 | In distribution | |
| IRR-TUBE-HF | In distribution | |
| 310.65S | In distribution | |
| 03.000.071S | In distribution | |
| 03.000.051S | In distribution | |
| 03.000.128S | In distribution | |
| 03.025.082 | In distribution | |
| 518.09 | In distribution | |
| 03.617.916 | In distribution | |
| SDCB | In distribution | |
| 310.141 | In distribution | |
| 03.000.031S | In distribution | |
| 05.505.003 | In distribution | |
| 03.168.007 | In distribution | |
| 05.001.065 | In distribution | |
| 03.000.037S | In distribution | |
| 532.110 | In distribution | |
| 316.238 | In distribution | |
| 03.000.323S | In distribution | |
| 519.50D | In distribution | |
| 03.000.143S | In distribution | |
| 310.27 | In distribution | |
| 05.001.221 | In distribution | |
| 03.000.049S | In distribution | |
| 03.000.041S | In distribution | |
| 03.000.074S | In distribution | |
| SD03.505.006 | In distribution | |
| 05.001.208 | In distribution | |
| 05.001.222 | In distribution | |
| 03.000.075S | In distribution | |
| 530.794 | In distribution | |
| 315.40S | In distribution | |
| 05.001.215 | In distribution | |
| 05.001.206 | In distribution | |
| 532.031 | In distribution | |
| CSRSC | In distribution | |
| 05.001.076 | In distribution | |
| 03.000.179S | In distribution | |
| 05.001.250 | In distribution | |
| 510.191 | In distribution | |
| 530.792 | In distribution | |
| 05.001.223 | In distribution | |
| 532.015 | In distribution | |
| 530.793 | In distribution | |
| IRR-CLIP-50 | In distribution | |
| 03.000.012S | In distribution | |
| 519.53D | In distribution | |
| 03.000.114S | In distribution | |
| ACB | In distribution | |
| 05.001.187 | In distribution | |
| 316.286 | In distribution | |
| 03.000.056S | In distribution | |
| 03.000.109S | In distribution | |
| 05.001.253 | In distribution | |
| 05.001.219 | In distribution | |
| 511.784 | In distribution | |
| 316.306 | In distribution | |
| 05.001.213 | In distribution | |
| 03.000.137S | In distribution | |
| 05.001.225 | In distribution | |
| 03.025.104 | In distribution | |
| 03.168.004 | In distribution | |
| 03.000.007S | In distribution | |
| 309.004S | In distribution | |
| 03.000.125S | In distribution | |
| 05.001.098 | In distribution | |
| 532.011 | In distribution | |
| 510.20 | In distribution | |
| 03.000.340S | In distribution | |
| 315.37S | In distribution | |
| 03.168.006 | In distribution | |
| 532.012 | In distribution | |
| 03.000.336S | In distribution | |
| 310.592 | In distribution | |
| 317.861 | In distribution | |
| 532.104 | In distribution | |
| 03.000.110S | In distribution | |
| 03.000.091S | In distribution | |
| 03.000.155S | In distribution | |
| 511.412 | In distribution | |
| 03.000.232S | In distribution | |
| 05.001.217 | In distribution | |
| 310.507 | In distribution | |
| 310.162 | In distribution | |
| 05.001.251 | In distribution | |
| 532.027 | In distribution | |
| 310.37 | In distribution | |
| 530.400.006.98 | In distribution | |
| 530.732 | In distribution | |
| IRR-CLIP-40 | In distribution | |
| 05.001.178.01S | In distribution | |
| 03.000.302S | In distribution | |
| 316.288 | In distribution | |
| IRR-CLIP-30 | Withdrawn | |
| 511.786 | Withdrawn | |
| 03.000.129S | Withdrawn | |
| 511.610 | Withdrawn | |
| 05.001.186 | Withdrawn | |
| IRR-CLIP-10 | Withdrawn | |
| 511.73 | Withdrawn | |
| 03.000.160S | Withdrawn | |
| 05.001.042 | Withdrawn | |
| 05.001.020 | Withdrawn | |
| 511.701 | Withdrawn | |
| 05.001.175 | Withdrawn | |
| 03.000.132S | Withdrawn | |
| 511.731 | Withdrawn | |
| 511.80 | Withdrawn | |
| 511.783 | Withdrawn | |
| 511.791 | Withdrawn | |
| 03.000.121S | Withdrawn | |
| 03.000.096S | Withdrawn | |
| 03.000.103S | Withdrawn | |
| 532.004 | Withdrawn | |
| 511.785 | Withdrawn | |
| 511.782 | Withdrawn | |
| 532.010 | Withdrawn | |
| IRR-CLIP-20 | Withdrawn | |
| 511.761 | Withdrawn | |
| IRR-CLIP-60 | Withdrawn | |
| 05.001.110 | Withdrawn | |
| 532.003 | Withdrawn | |
| 518.01 | Withdrawn | |
| 05.001.104 | Withdrawn | |
| 532.002 | Withdrawn | |
| 05.001.053 | Withdrawn | |
| 511.75 | Withdrawn | |
| 511.615 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZX | Imedicom Co., Ltd. | 441 |
| Arthrex® | Arthrex, Inc. | 391 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Stryker GmbH | 284 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 231 |
| Brasseler EZX | Imedicom Co., Ltd. | 187 |
| Conserve® | Microport Orthopedics Inc. | 158 |
| R3 | Smith & Nephew, Inc. | 147 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Exactech, Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2016-11-01 | Class II | Under Investigation by firm | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. | 84 units | 2017-06-01 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-31 | Class II | Labeling False and Misleading | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. | 19 units | 2017-02-02 |
| Synthes Gmbh | 510(k) number | 2014-12-19 | Class II | Process design | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. | 249 | 2016-05-19 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-04-15 | Class II | Process design | Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The “on” and “lock” labels were interchanged. | 290 | 2016-09-14 |
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.