Yukon OCT Spinal System
Lateral Offset Connector, Closed Size Ø3.5/4.0 mm 15 mm
11manufacturers in China registered for this device type
485catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K193129 |
| Record published | 2018-02-15 |
| Record revised | 2026-04-20 (version 11) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 3.5 to 6 mm; length 6 to 600 mm; width 3.5 to 50 mm; height 3.5 to 8 mm; angle 40 to 115 ° |
| Distribution end date | 2024-06-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7601-70000-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04518 | Outer Diameter 4.5 mm | In distribution |
| 7601-64045 | Length 45 mm | In distribution |
| 7601-15214 | Length 14 mm | In distribution |
| 7601-73515A | Outer Diameter 3.5 mm | In distribution |
| 7601-80015 | Height 4.5 mm | In distribution |
| 7601-80036 | Outer Diameter 3.5 mm | In distribution |
| 7601-04020-G1 | Outer Diameter 4 mm | In distribution |
| 7611-535500-55 | Length 500 mm | In distribution |
| 7601-04046-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04514M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-05034M | Outer Diameter 5 mm | In distribution |
| 7601-05046 | Outer Diameter 5 mm | In distribution |
| 7601-04028L | Length 28 mm | In distribution |
| 7601-03544-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-80029-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03538M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-15715 | Outer Diameter 5.75 mm | In distribution |
| 7601-03522L | Length 22 mm | In distribution |
| 7601-03514M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-15707-G1 | Length 7 mm | In distribution |
| 7601-15706 | Length 6 mm | In distribution |
| 7601-73510S | Outer Diameter 3.5 mm | In distribution |
| 7601-04032 | Outer Diameter 4 mm | In distribution |
| 7601-04524M | Length 24 mm | In distribution |
| 7601-80001 | Outer Diameter 3.5 mm | In distribution |
| 7601-04546M-G1 | Length 46 mm | In distribution |
| 7601-05032M-G1 | Outer Diameter 5 mm | In distribution |
| 7611-64080-G1 | Length 80 mm | In distribution |
| 7601-03526 | Length 26 mm | In distribution |
| 7601-83545E | Outer Diameter 4.5 mm | In distribution |
| 7601-04048M-G1 | Length 48 mm | In distribution |
| 7601-73515C-G1 | Length 15 mm | In distribution |
| 7601-03530-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04510-G1 | Length 10 mm | In distribution |
| 7601-03522M | Length 22 mm | In distribution |
| 7611-540100 | Length 100 mm | In distribution |
| 7601-05028 | Length 28 mm | In distribution |
| 7601-73525A-G1 | Outer Diameter 3.5 mm | In distribution |
| 7611-640100-G1 | Length 100 mm | In distribution |
| 7601-63590 | Outer Diameter 3.5 mm | In distribution |
| 7601-05022 | Outer Diameter 5 mm | In distribution |
| 7601-63580-G1 | Length 80 mm | In distribution |
| 7601-04046 | Length 46 mm | In distribution |
| 7601-10003 | In distribution | |
| 7611-640215-115 | Angle 115 ° | In distribution |
| 7601-63560 | Outer Diameter 3.5 mm | In distribution |
| 7601-04544 | Length 44 mm | In distribution |
| 7601-03524 | Length 24 mm | In distribution |
| 7601-03514 | Outer Diameter 3.5 mm | In distribution |
| 7601-04528 | Length 28 mm | In distribution |
| 7611-63550-G1 | Outer Diameter 3.5 mm | In distribution |
| 7611-B40200 | Length 200 mm | In distribution |
| 7601-04020M | Length 20 mm | In distribution |
| 7611-B40120 | Outer Diameter 4 mm | In distribution |
| 7601-05026T | Outer Diameter 5 mm | In distribution |
| 7601-03546M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05028M | Outer Diameter 5 mm | In distribution |
| 7601-14508-G1 | Length 8 mm | In distribution |
| 7601-05028T | Outer Diameter 5 mm | In distribution |
| 7601-04014M-G1 | Length 14 mm | In distribution |
| 7601-04020M-G1 | Length 20 mm | In distribution |
| 7601-80004-G1 | Width 5 mm | In distribution |
| 7601-04550 | Outer Diameter 4.5 mm | In distribution |
| 7601-04020 | Outer Diameter 4 mm | In distribution |
| 7601-05038T | Outer Diameter 5 mm | In distribution |
| 7601-04036L | Outer Diameter 4 mm | In distribution |
| 7601-04046M-G1 | Outer Diameter 4 mm | In distribution |
| 7601-05042-G1 | Outer Diameter 5 mm | In distribution |
| 7601-80035 | Width 3.5 mm | In distribution |
| 7601-04544-G1 | Length 44 mm | In distribution |
| 7601-04034L | Outer Diameter 4 mm | In distribution |
| 7601-80033-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03526L-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05018M | Outer Diameter 5 mm | In distribution |
| 7601-03536L | Length 36 mm | In distribution |
| 7611-64070-G1 | Outer Diameter 4 mm | In distribution |
| 7601-64065 | Length 65 mm | In distribution |
| 7601-04050-G1 | Outer Diameter 4 mm | In distribution |
| 7601-15207-G1 | Outer Diameter 5.25 mm | In distribution |
| 7601-63540-G1 | Length 40 mm | In distribution |
| 7601-83535C | Outer Diameter 3.5 mm | In distribution |
| 7601-80006-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-15210-G1 | Length 10 mm | In distribution |
| 7601-14512-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-04032L-G1 | Outer Diameter 4 mm | In distribution |
| 7611-B40550 | Outer Diameter 4 mm | In distribution |
| 7611-635300 | Length 300 mm | In distribution |
| 7601-03522 | Length 22 mm | In distribution |
| 7601-04016 | Outer Diameter 4 mm | In distribution |
| 7601-04544M | Outer Diameter 4.5 mm | In distribution |
| 7601-80005 | Width 5 mm | In distribution |
| 7601-05036M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-05028M-G1 | Length 28 mm | In distribution |
| 7601-64090-G1 | Length 90 mm | In distribution |
| 7601-80000 | Height 3.5 mm | In distribution |
| 7601-04522-G1 | Length 22 mm | In distribution |
| 7601-03526L | Length 26 mm | In distribution |
| 7601-64045-G1 | Outer Diameter 4 mm | In distribution |
| 7601-80046-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03524L | Length 24 mm | In distribution |
| 7601-04514-G1 | Length 14 mm | In distribution |
| 7601-14507 | Outer Diameter 4.5 mm | In distribution |
| 7601-73530-G1 | Length 30 mm | In distribution |
| 7601-80044 | Outer Diameter 3.5 mm | In distribution |
| 7601-73520A-G1 | Length 20 mm | In distribution |
| 7601-83555C | Outer Diameter 3.5 mm | In distribution |
| 7601-04012 | Length 12 mm | In distribution |
| 7611-540500-55 | Length 500 mm | In distribution |
| 7601-04536 | Length 36 mm | In distribution |
| 7601-04010M-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04548 | Length 48 mm | In distribution |
| 7601-05018M-G1 | Length 18 mm | In distribution |
| 7601-04512-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-73515-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05038M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-05016-G1 | Length 16 mm | In distribution |
| 7601-04516 | Outer Diameter 4.5 mm | In distribution |
| 7601-04016L-G1 | Length 16 mm | In distribution |
| 7601-03518M-G1 | Length 18 mm | In distribution |
| 7601-640110-G1 | Length 110 mm | In distribution |
| 7601-05050M-G1 | Length 50 mm | In distribution |
| 7601-73525C | Length 25 mm | In distribution |
| 7601-03534M-G1 | Length 34 mm | In distribution |
| 7611-63580-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03518M | Outer Diameter 3.5 mm | In distribution |
| 7601-14508 | Length 8 mm | In distribution |
| 7601-540300-55S | Outer Diameter 4 mm | In distribution |
| 7601-15214-G1 | Length 14 mm | In distribution |
| 7601-04540T | Length 40 mm | In distribution |
| 7601-83535B | Outer Diameter 3.5 mm | In distribution |
| 7601-05032 | Length 32 mm | In distribution |
| 7601-83555G | Outer Diameter 3.5 mm | In distribution |
| 7601-04524-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-80005-G1 | Width 5 mm | In distribution |
| 7601-535300-55 | Outer Diameter 5.5 mm | In distribution |
| 7601-05012 | Length 12 mm | In distribution |
| 7601-04018 | Outer Diameter 4 mm | In distribution |
| 7601-03522L-G1 | Length 22 mm | In distribution |
| 7601-04534 | Length 34 mm | In distribution |
| 7601-03542-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-73520S | Length 20 mm | In distribution |
| 7601-03550 | Length 50 mm | In distribution |
| 7611-63590 | Length 90 mm | In distribution |
| 7611-63595-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-80043 | Width 3.5 mm | In distribution |
| 7601-05032-G1 | Length 32 mm | In distribution |
| 7601-04516-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-03536 | Length 36 mm | In distribution |
| 7601-04538-G1 | Length 38 mm | In distribution |
| 7601-03510-G1 | Length 10 mm | In distribution |
| 7601-05020 | Length 20 mm | In distribution |
| 7601-635110 | Outer Diameter 3.5 mm | In distribution |
| 7601-15208 | Outer Diameter 5.25 mm | In distribution |
| 7601-05020M-G1 | Length 20 mm | In distribution |
| 7601-04040 | Length 40 mm | In distribution |
| 7601-04050M-G1 | Outer Diameter 4 mm | In distribution |
| 7611-63575-G1 | Length 75 mm | In distribution |
| 7601-05014 | Outer Diameter 5 mm | In distribution |
| 7601-64060-G1 | Length 60 mm | In distribution |
| 7601-05048 | Outer Diameter 5 mm | In distribution |
| 7601-63535 | Length 35 mm | In distribution |
| 7601-04030L-G1 | Length 30 mm | In distribution |
| 7601-04026 | Outer Diameter 4 mm | In distribution |
| 7601-63575-G1 | Length 75 mm | In distribution |
| 7611-63540-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-540500-60 | Outer Diameter 6 mm | In distribution |
| 7601-73530 | Length 30 mm | In distribution |
| 7601-04034 | Outer Diameter 4 mm | In distribution |
| 7601-73510V | Length 10 mm | In distribution |
| 7601-03546 | Length 46 mm | In distribution |
| 7601-635105-G1 | Length 105 mm | In distribution |
| 7601-04018-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04524 | Length 24 mm | In distribution |
| 7601-04520-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-04024L | Length 24 mm | In distribution |
| 7601-05044-G1 | Outer Diameter 5 mm | In distribution |
| 7601-73747H | In distribution | |
| 7601-15710 | Length 10 mm | In distribution |
| 7601-04034M-G1 | Length 34 mm | In distribution |
| 7601-63525-G1 | Outer Diameter 3.5 mm | In distribution |
| 7611-B40300 | Outer Diameter 4 mm | In distribution |
| 7601-73515A-G1 | Angle 40 ° | In distribution |
| 7611-63595 | Outer Diameter 3.5 mm | In distribution |
| 7601-05030M | Outer Diameter 5 mm | In distribution |
| 7601-05012-G1 | Outer Diameter 5 mm | In distribution |
| 7601-70004 | Length 60 mm | In distribution |
| 7601-04526 | Length 26 mm | In distribution |
| 7601-04524T | Length 24 mm | In distribution |
| 7611-63530 | Length 30 mm | In distribution |
| 7601-80049-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03512 | Length 12 mm | In distribution |
| 7601-80017-G1 | Height 8 mm | In distribution |
| 7611-B40240 | Outer Diameter 4 mm | In distribution |
| 7601-03540 | Length 40 mm | In distribution |
| 7601-10002 | In distribution | |
| 7601-03514M | Outer Diameter 3.5 mm | In distribution |
| 7601-73530C | Outer Diameter 3.5 mm | In distribution |
| 7601-04022-G1 | Outer Diameter 4 mm | In distribution |
| 7601-80038-G1 | Height 3.5 mm | In distribution |
| 7601-63555 | Outer Diameter 3.5 mm | In distribution |
| 7601-05010M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-04528M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-73515S | Length 15 mm | In distribution |
| 7611-63540 | Length 40 mm | In distribution |
| 7601-63585-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-63555-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04526M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-04018L-G1 | Length 18 mm | In distribution |
| 7601-15212 | Length 12 mm | In distribution |
| 7601-80039-G1 | Height 4.5 mm | In distribution |
| 7601-73515S-G1 | Length 15 mm | In distribution |
| 7601-04010-G1 | Length 10 mm | In distribution |
| 7601-04044M-G1 | Length 44 mm | In distribution |
| 7601-80011-G1 | Width 3.5 mm | In distribution |
| 7601-03516L | Outer Diameter 3.5 mm | In distribution |
| 7611-63570-G1 | Length 70 mm | In distribution |
| 7601-80031 | Width 5 mm | In distribution |
| 7601-15711-G1 | Length 11 mm | In distribution |
| 7601-04032L | Length 32 mm | In distribution |
| 7601-05034M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-15709 | Length 9 mm | In distribution |
| 7601-04040L | Length 40 mm | In distribution |
| 7601-04030-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04520 | Outer Diameter 4.5 mm | In distribution |
| 7601-03548M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05040 | Length 40 mm | In distribution |
| 7601-540500-55 | Outer Diameter 5.5 mm | In distribution |
| 7601-03534L-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-540500-55S | Outer Diameter 4 mm | In distribution |
| 7601-04520M-G1 | Length 20 mm | In distribution |
| 7601-05050 | Length 50 mm | In distribution |
| 7601-05034T | Length 34 mm | In distribution |
| 7601-03524L-G1 | Length 24 mm | In distribution |
| 7601-10001-G1 | In distribution | |
| 7611-64085-G1 | Length 85 mm | In distribution |
| 7601-80048-G1 | Width 5 mm | In distribution |
| 7611-635105-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-63545 | Length 45 mm | In distribution |
| 7601-14507-G1 | Outer Diameter 4.5 mm | In distribution |
| 7611-63585-G1 | Length 85 mm | In distribution |
| 7601-73525A | Angle 40 ° | In distribution |
| 7601-73515V-G1 | Length 15 mm | In distribution |
| 7601-05046-G1 | Outer Diameter 5 mm | In distribution |
| 7601-04032M-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04042-G1 | Length 42 mm | In distribution |
| 7601-80003-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03532M | Outer Diameter 3.5 mm | In distribution |
| 7601-73525 | Length 25 mm | In distribution |
| 7601-80007-G1 | Height 8 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| K2M, Inc. | UDI-DI | 2022-06-13 | Class II | Under Investigation by firm | Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactio | 53 devices (19 US; 34 OUS) | |
| K2M, Inc. | UDI-DI | 2020-12-14 | Class II | Employee error | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). | 248 units/1 each | 2023-07-11 |
| K2M, Inc. | 510(k) number | 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.