Yukon OCT Spinal System
Provisional Screwdriver Tapered w/Handle Size 15 Tapered wit
53manufacturers in China registered for this device type
174catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2022-06-01 |
| Record revised | 2026-04-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 2 to 5 mm |
| Distribution end date | 2024-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7601-90093 | In distribution | |
| SP-4059 | In distribution | |
| 7601-90105 | In distribution | |
| SP-3034-03 | Outer Diameter 4 mm | In distribution |
| SP-4235 | Size 15 Hexalobe | In distribution |
| PRO-1096-01 | Outer Diameter 3 mm | In distribution |
| SP-4016-02 | Rod Slot Diameter Ø4.0 mm | In distribution |
| 7601-90106 | In distribution | |
| 7601-90059 | In distribution | |
| PRO-1102-03 | Outer Diameter 4 mm | In distribution |
| SP-4061 | In distribution | |
| SP-4130-02 | Outer Diameter 3.5 mm | In distribution |
| 7601-90192 | In distribution | |
| PRO-1189-03 | Outer Diameter 4 mm | In distribution |
| SP-3062 | In distribution | |
| 7601-90103 | In distribution | |
| 7601-90011 | In distribution | |
| SP-4211 | In distribution | |
| PRO-1189-01 | Outer Diameter 3 mm | In distribution |
| 7601-90101 | In distribution | |
| 7601-90060 | In distribution | |
| 7601-90186 | In distribution | |
| 7601-90104 | In distribution | |
| PRO-1060 | In distribution | |
| SP-4130-04 | Outer Diameter 4.5 mm | In distribution |
| 7601-90098 | In distribution | |
| 7601-90005 | In distribution | |
| 7601-90007 | In distribution | |
| 7601-90000 | In distribution | |
| 7601-90190 | In distribution | |
| 7601-90123 | In distribution | |
| 7601-90094 | In distribution | |
| 7601-90012 | In distribution | |
| PRO-1102-01 | Outer Diameter 3 mm | In distribution |
| 7601-90008 | In distribution | |
| 7601-90052 | In distribution | |
| SP-4130-03 | Outer Diameter 4 mm | In distribution |
| 7601-90085 | In distribution | |
| 7601-90054 | In distribution | |
| PRO-1314 | In distribution | |
| 7601-90078 | In distribution | |
| 7601-90049 | In distribution | |
| 7601-90168 | In distribution | |
| 7601-90198 | In distribution | |
| SP-4048 | In distribution | |
| 7601-90179 | In distribution | |
| SP-3034-04 | Outer Diameter 4.5 mm | In distribution |
| 7601-90075 | In distribution | |
| 7601-90087 | In distribution | |
| SP-4197 | In distribution | |
| 7601-90002 | In distribution | |
| 7601-90061 | In distribution | |
| 7601-90096 | In distribution | |
| SP-4016-01 | Rod Slot Diameter Ø3.5 mm | In distribution |
| SP-4128 | Outer Diameter 2 mm | In distribution |
| PRO-1096-03 | Outer Diameter 4 mm | In distribution |
| 7601-90050 | In distribution | |
| PRO-1387 | In distribution | |
| 7601-90174 | In distribution | |
| 7601-90204 | Outer Diameter 3.5 mm | In distribution |
| 7601-90175 | In distribution | |
| 7601-90187 | In distribution | |
| PRO-1102-05 | Outer Diameter 5 mm | In distribution |
| 7601-90124 | In distribution | |
| 7601-90056 | In distribution | |
| 7601-90089 | In distribution | |
| 7601-90001 | In distribution | |
| PRO-1364-05 | Outer Diameter 5 mm | In distribution |
| 7601-90053 | In distribution | |
| PRO-1364-02 | Outer Diameter 3.5 mm | In distribution |
| 7601-90055 | In distribution | |
| 7601-90009 | In distribution | |
| 7601-90178 | In distribution | |
| SP-3034-05 | Outer Diameter 5 mm | In distribution |
| 7601-90130 | In distribution | |
| SP-4058 | Torque Limit 2.25 N-m | In distribution |
| SP-4167 | In distribution | |
| SP-4236 | In distribution | |
| SP-3228 | In distribution | |
| SP-4130-05 | Outer Diameter 5 mm | In distribution |
| PRO-1072 | In distribution | |
| 7601-90134 | In distribution | |
| SP-4203 | In distribution | |
| PRO-1189-05 | Outer Diameter 5 mm | In distribution |
| 7601-90072 | In distribution | |
| 7601-90070 | In distribution | |
| PRO-1102-02 | Outer Diameter 3.5 mm | In distribution |
| 7601-90203 | In distribution | |
| SP-4094-02 | In distribution | |
| 7601-90173 | In distribution | |
| 7601-90080 | In distribution | |
| SP-4068-01 | In distribution | |
| PRO-1337 | In distribution | |
| SP-4234 | In distribution | |
| 7601-90095 | In distribution | |
| 7601-90099 | In distribution | |
| SP-4251-01 | In distribution | |
| PRO-1364-04 | Outer Diameter 4.5 mm | In distribution |
| PRO-1102-04 | Outer Diameter 4.5 mm | In distribution |
| PRO-1218 | In distribution | |
| PRO-1184 | In distribution | |
| 7601-90169 | In distribution | |
| 7601-90073 | In distribution | |
| SP-4102 | In distribution | |
| SP-4152 | In distribution | |
| 7601-90003 | In distribution | |
| SP-4198 | In distribution | |
| 7601-90092 | In distribution | |
| PRO-1364-01 | Outer Diameter 3 mm | In distribution |
| 7601-90121 | In distribution | |
| 7601-90088 | In distribution | |
| SP-4251-02 | In distribution | |
| 7601-90077 | In distribution | |
| 7601-90100 | In distribution | |
| PRO-1364-03 | Outer Diameter 4 mm | In distribution |
| 7601-90189 | In distribution | |
| PRO-1135 | In distribution | |
| 7601-90082 | In distribution | |
| SP-4083-03 | In distribution | |
| 7601-90013 | In distribution | |
| 7601-90051 | In distribution | |
| 7601-90138 | In distribution | |
| 7601-90004 | In distribution | |
| 7601-90006 | In distribution | |
| 7601-90191 | In distribution | |
| SP-4179-01 | In distribution | |
| 7601-90086 | In distribution | |
| SP-4083-01 | In distribution | |
| SP-4179-02 | In distribution | |
| 7601-90064 | In distribution | |
| SP-4016-03 | Rod Slot Diameter Ø3.5 mm | In distribution |
| PRO-1189-04 | Outer Diameter 4.5 mm | In distribution |
| SP-4016-04 | Rod Slot Diameter Ø4.0 mm | In distribution |
| 7601-90122 | In distribution | |
| SP-4083-02 | In distribution | |
| 7601-90171 | In distribution | |
| 7601-90172 | In distribution | |
| PRO-1096-02 | Outer Diameter 3.5 mm | In distribution |
| 7601-90097 | In distribution | |
| SP-3034-02 | Outer Diameter 3.5 mm | In distribution |
| 7601-90084 | In distribution | |
| 7601-90091 | In distribution | |
| 7601-90081 | In distribution | |
| 7601-90076 | In distribution | |
| SP-4130-01 | Outer Diameter 3 mm | In distribution |
| 7601-90063 | In distribution | |
| PRO-1042 | Size 15 Hexalobe | In distribution |
| SP-4009 | In distribution | |
| SP-4094-01 | In distribution | |
| PRO-1193 | In distribution | |
| 7601-90090 | In distribution | |
| PRO-1316 | In distribution | |
| 7601-90018 | In distribution | |
| 7601-90071 | In distribution | |
| PRO-1189-02 | Outer Diameter 3.5 mm | In distribution |
| SP-3034-01 | Outer Diameter 3 mm | In distribution |
| 7601-90120 | In distribution | |
| 7601-90102 | In distribution | |
| PRO-1264 | In distribution | |
| 7601-90183 | In distribution | |
| 7601-90188 | In distribution | |
| 7601-90079 | In distribution | |
| SP-4068-02 | In distribution | |
| 7601-90062 | In distribution | |
| 7601-90170 | In distribution | |
| PRO-1408 | In distribution | |
| 7601-90010 | In distribution | |
| PRO-1096-04 | Outer Diameter 4.5 mm | In distribution |
| 7601-90132 | In distribution | |
| SP-4011-01 | Withdrawn | |
| SP-4011-04 | Withdrawn | |
| SP-4011-02 | Withdrawn | |
| SP-4011-03 | Withdrawn | |
| 7601-90180 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| K2M, Inc. | UDI-DI | 2020-11-03 | Class II | Nonconforming Material/Component | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on. | 4 devices | 2021-01-12 |
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.