Ortho Solutions Sterile Drill Bits
The FDA summary describes Ortho Solutions sterile single-use drill bits in different sizes and lengths, with fluted designs and solid or cannulated forms. Their stated use is to bore a hole…
The FDA summary describes Ortho Solutions sterile single-use drill bits in different sizes and lengths, with fluted designs and solid or cannulated forms.
Their stated use is to bore a hole in bone for insertion of a screw, wire, cable, plate, pin or bolt.
Listed Item
4.0MM Cann. Screw Cannulated Drill 2.7MM With AO Coupling
Supply
The filing says the drill bits are provided sterile and identifies gamma radiation as the sterilization method. The bits have various end coupling mechanisms.
23manufacturers in China registered for this device type
119catalogue numbers in this listing
1510(k) clearance
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 | Ortho Solutions Inc, United States |
|---|---|
| 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 | Complaint-file establishment |
| 510(k) | K102743 |
| Record published | 2016-02-19 |
| Record revised | 2022-09-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Cardboard box of 5, cardboard box of 10, 05055662931266 of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS200022L | In distribution | |
| OSD-7516 | In distribution | |
| OSH-556 | In distribution | |
| OSS-805 | In distribution | |
| OSS-860 | In distribution | |
| OSS-3115 | In distribution | |
| OSS-2328 | In distribution | |
| OS319050 | In distribution | |
| OS310101S | In distribution | |
| OSH-561 | In distribution | |
| OSH-9226 | In distribution | |
| OS200132 | In distribution | |
| OS200429 | In distribution | |
| OSS-3225 | In distribution | |
| OSS-3111 | In distribution | |
| OS200135L | In distribution | |
| OSS-33125 | In distribution | |
| OS200035 | In distribution | |
| OSS-86124 | In distribution | |
| OS200115 | In distribution | |
| OS307202 | In distribution | |
| OSH-23240 | In distribution | |
| OSH-543 | In distribution | |
| OSS-527100 | In distribution | |
| OSH-523 | In distribution | |
| OSS-6325 | In distribution | |
| OSH-2339 | In distribution | |
| OSS-802 | In distribution | |
| OSH-586 | In distribution | |
| OS307106 | In distribution | |
| OSS-3125 | In distribution | |
| OS307203 | In distribution | |
| OSS-840 | In distribution | |
| OS200325 | In distribution | |
| OSH-71553 | In distribution | |
| OS323016 | In distribution | |
| OS200015 | In distribution | |
| OS321110 | In distribution | |
| OSD-7256 | In distribution | |
| OS307104 | In distribution | |
| OS319050 | In distribution | |
| OSD-7100 | In distribution | |
| OSS-803 | In distribution | |
| OSS-851 | In distribution | |
| OS200427 | In distribution | |
| OSA19-118 | In distribution | |
| OS200120 | In distribution | |
| OSD-7526 | In distribution | |
| OS307100 | In distribution | |
| OSS-883 | In distribution | |
| OSS-3114 | In distribution | |
| OS307102 | In distribution | |
| OSS-33111 | In distribution | |
| OS307204 | In distribution | |
| OSH-258 | In distribution | |
| OS200020LC | In distribution | |
| OS200025 | In distribution | |
| OSH-2232 | In distribution | |
| OSA11-905 | In distribution | |
| OSS-3108 | In distribution | |
| OS200367 | In distribution | |
| OS309008 | In distribution | |
| OS309008 | In distribution | |
| OS200132L | In distribution | |
| OSS-6275 | In distribution | |
| OSH-2243 | In distribution | |
| OS200125ST | In distribution | |
| OSS-33114 | In distribution | |
| OSS-820 | In distribution | |
| OS200127 | In distribution | |
| OS200350 | In distribution | |
| OSS-8361 | In distribution | |
| OSS-2265 | In distribution | |
| OS200145L | In distribution | |
| OSS-809 | In distribution | |
| OSS-4790 | In distribution | |
| OS328017 | In distribution | |
| OSS-3212 | In distribution | |
| OSD-5103 | In distribution | |
| OSH-2244 | In distribution | |
| OS321110 | In distribution | |
| OS307205 | In distribution | |
| OSH-9230 | In distribution | |
| OSS-818 | In distribution | |
| OS200145 | In distribution | |
| OSS-53590 | In distribution | |
| OS200032 | In distribution | |
| OSS-33225 | In distribution | |
| OSH-273 | In distribution | |
| OSS-882 | In distribution | |
| OS200132S | In distribution | |
| OS323015 | In distribution | |
| OS200120L | In distribution | |
| OS307206 | In distribution | |
| OSS-855 | In distribution | |
| OSS-33412 | In distribution | |
| OS323016 | In distribution | |
| OSH-2201 | In distribution | |
| OS319052 | In distribution | |
| OSH-2241 | In distribution | |
| OSS-885 | In distribution | |
| OSS-86153 | In distribution | |
| OSH-9228 | In distribution | |
| OSS-33105 | In distribution | |
| OSS-856 | In distribution | |
| OSS-3414 | In distribution | |
| OSD-5100 | In distribution | |
| OSH-23233 | In distribution | |
| OSH-2238 | In distribution | |
| OSD-7101 | In distribution | |
| OSS-852 | In distribution | |
| OS200128 | In distribution | |
| OSA19-115 | In distribution | |
| OSOM-1070 | In distribution | |
| OSS-876 | In distribution | |
| OSS-800 | In distribution | |
| OS307105 | In distribution | |
| OS307103 | In distribution | |
| OS200135 | In distribution |
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 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Synthes Gmbh | 226 |
| 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 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102743 | 2011-01-20 |
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.