Yukon OCT Spinal System
Lateral Offset Connector Side Loading Angled Size 30 mm
4manufacturers in China registered for this device type
451catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| 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 |
|---|---|---|
| 7601-80023-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-73530A-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-15714-G1 | Length 14 mm | In distribution |
| 7601-05030T | Length 30 mm | In distribution |
| 7601-73530A | Angle 40 ° | In distribution |
| 7601-04016M-G1 | Length 16 mm | In distribution |
| 7601-04530M | Length 30 mm | In distribution |
| 7601-540300-55 | Length 300 mm | In distribution |
| 7601-15213 | Length 13 mm | In distribution |
| 7611-640125-115 | Length 125 mm | In distribution |
| 7601-63575 | Length 75 mm | In distribution |
| 7601-04540M | Outer Diameter 4.5 mm | In distribution |
| 7601-05038-G1 | Length 38 mm | In distribution |
| 7601-04528T | Outer Diameter 4.5 mm | In distribution |
| 7601-03526M | Outer Diameter 3.5 mm | In distribution |
| 7601-540100-G1 | Length 100 mm | In distribution |
| 7601-80021-G1 | Width 3.5 mm | In distribution |
| 7601-80028-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-15713-G1 | Outer Diameter 5.75 mm | In distribution |
| 7601-80021 | Height 8 mm | In distribution |
| 7611-B4080 | Outer Diameter 4 mm | In distribution |
| 7601-05010-G1 | Length 10 mm | In distribution |
| 7601-63565-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-83535F | Outer Diameter 3.5 mm | In distribution |
| 7601-80010-G1 | Height 3.5 mm | In distribution |
| 7601-80035-G1 | Width 3.5 mm | In distribution |
| 7601-80041 | Width 5 mm | In distribution |
| 7601-04510 | Length 10 mm | In distribution |
| 7601-04534T | Length 34 mm | In distribution |
| 7601-14515 | Outer Diameter 4.5 mm | In distribution |
| 7601-80012 | Height 6 mm | In distribution |
| 7601-73520C-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-70003 | Outer Diameter 3.5 mm | In distribution |
| 7601-83545B | Outer Diameter 3.5 mm | In distribution |
| 7611-63555 | Length 55 mm | In distribution |
| 7601-03516M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03540M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05030M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-80010 | Height 3.5 mm | In distribution |
| 7611-640105-G1 | Length 105 mm | In distribution |
| 7601-80038 | Height 3.5 mm | In distribution |
| 7601-04542M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-03534 | Length 34 mm | In distribution |
| 7601-80013-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04040-G1 | Outer Diameter 4 mm | In distribution |
| 7611-B40100 | Outer Diameter 4 mm | In distribution |
| 7611-63535-G1 | Length 35 mm | In distribution |
| 7601-03532M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-73520C | Outer Diameter 3.5 mm | In distribution |
| 7601-83535D-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03528-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03530L-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-63545-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04540M-G1 | Length 40 mm | In distribution |
| 7601-04022M-G1 | Outer Diameter 4 mm | In distribution |
| 7611-63585 | Length 85 mm | In distribution |
| 7601-05032T | Length 32 mm | In distribution |
| 7601-635100 | Outer Diameter 3.5 mm | In distribution |
| 7611-64030-G1 | Outer Diameter 4 mm | In distribution |
| 7601-05036T | Length 36 mm | In distribution |
| 7601-03550M | Length 50 mm | In distribution |
| 7601-80022-G1 | Height 3.5 mm | In distribution |
| 7601-635120 | Outer Diameter 3.5 mm | In distribution |
| 7601-64065-G1 | Length 65 mm | In distribution |
| 7601-80017 | Width 5 mm | In distribution |
| 7601-04012M-G1 | Outer Diameter 4 mm | In distribution |
| 7601-73510V-G1 | Length 10 mm | In distribution |
| 7601-73530V-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03540L | Length 40 mm | In distribution |
| 7601-03520 | Length 20 mm | In distribution |
| 7601-73510 | Outer Diameter 3.5 mm | In distribution |
| 7611-54080-G1 | Outer Diameter 4 mm | In distribution |
| 7611-540120 | Outer Diameter 4 mm | In distribution |
| 7611-63560-G1 | Length 60 mm | In distribution |
| 7601-05026M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-15709-G1 | Length 9 mm | In distribution |
| 7601-80034 | Outer Diameter 3.5 mm | In distribution |
| 7601-04518M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-05020-G1 | Outer Diameter 5 mm | In distribution |
| 7601-03530M | Outer Diameter 3.5 mm | In distribution |
| 7611-B4080-G1 | Length 80 mm | In distribution |
| 7601-73525V | Length 25 mm | In distribution |
| 7611-63575 | Outer Diameter 3.5 mm | In distribution |
| 7601-70004-G1 | Length 60 mm | In distribution |
| 7601-04538T | Length 38 mm | In distribution |
| 7601-15211-G1 | Length 11 mm | In distribution |
| 7601-04548-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-04038L-G1 | Length 38 mm | In distribution |
| 7601-03538L | Length 38 mm | In distribution |
| 7601-03516 | Outer Diameter 3.5 mm | In distribution |
| 7601-64075 | Length 75 mm | In distribution |
| 7611-64095-G1 | Outer Diameter 4 mm | In distribution |
| 7601-80030-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-80046 | Height 3.5 mm | In distribution |
| 7601-04544M-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-80032-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04030 | Outer Diameter 4 mm | In distribution |
| 7601-05034 | Length 34 mm | In distribution |
| 7601-04036L-G1 | Length 36 mm | In distribution |
| 7601-15216 | Outer Diameter 5.25 mm | In distribution |
| 7601-83535C-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04542 | Outer Diameter 4.5 mm | In distribution |
| 7601-80020-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-63560-G1 | Length 60 mm | In distribution |
| 7601-04032-G1 | Outer Diameter 4 mm | In distribution |
| 7611-64055-G1 | Outer Diameter 4 mm | In distribution |
| 7611-64025-G1 | Length 25 mm | In distribution |
| 7601-14514-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-73510C-G1 | Length 10 mm | In distribution |
| 7601-83535A | Outer Diameter 3.5 mm | In distribution |
| 7611-64045-G1 | Length 45 mm | In distribution |
| 7601-04532T | Length 32 mm | In distribution |
| 7601-64035-G1 | Outer Diameter 4 mm | In distribution |
| 7601-15209-G1 | Length 9 mm | In distribution |
| 7601-05026 | Length 26 mm | In distribution |
| 7601-04536T | Length 36 mm | In distribution |
| 7601-83535A-G1 | Outer Diameter 3.5 mm | In distribution |
| 7611-63535 | Length 35 mm | In distribution |
| 7601-03522-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04022L-G1 | Length 22 mm | In distribution |
| 7601-03520-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04048-G1 | Length 48 mm | In distribution |
| 7601-80016-G1 | Height 6 mm | In distribution |
| 7601-15714 | Outer Diameter 5.75 mm | In distribution |
| 7601-04012M | Outer Diameter 4 mm | In distribution |
| 7601-03512M | Outer Diameter 3.5 mm | In distribution |
| 7601-03530 | Outer Diameter 3.5 mm | In distribution |
| 7601-15706-G1 | Outer Diameter 5.75 mm | In distribution |
| 7601-04522 | Length 22 mm | In distribution |
| 7601-14506-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-04036 | Outer Diameter 4 mm | In distribution |
| 7601-64070-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04014 | Outer Diameter 4 mm | In distribution |
| 7601-03546-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04028M-G1 | Length 28 mm | In distribution |
| 7601-03550-G1 | Length 50 mm | In distribution |
| 7601-05030-G1 | Length 30 mm | In distribution |
| 7601-03520M | Length 20 mm | In distribution |
| 7601-04540 | Outer Diameter 4.5 mm | In distribution |
| 7601-03518 | Length 18 mm | In distribution |
| 7601-04042M-G1 | Length 42 mm | In distribution |
| 7601-03532L | Length 32 mm | In distribution |
| 7601-73520-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03528L | Outer Diameter 3.5 mm | In distribution |
| 7601-80044-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-03548M | Length 48 mm | In distribution |
| 7601-05042M-G1 | Length 42 mm | In distribution |
| 7601-64080-G1 | Length 80 mm | In distribution |
| 7601-05024M | Outer Diameter 5 mm | In distribution |
| 7601-04550M-G1 | Length 50 mm | In distribution |
| 7601-63570-G1 | Length 70 mm | In distribution |
| 7601-73515 | Length 15 mm | In distribution |
| 7601-04536-G1 | Length 36 mm | In distribution |
| 7601-03518-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04520T | Outer Diameter 4.5 mm | In distribution |
| 7601-03542M-G1 | Length 42 mm | In distribution |
| 7601-03532L-G1 | Length 32 mm | In distribution |
| 7611-63545 | Length 45 mm | In distribution |
| 7601-80009 | Outer Diameter 3.5 mm | In distribution |
| 7601-63595-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-63585 | Outer Diameter 3.5 mm | In distribution |
| 7611-63560 | Length 60 mm | In distribution |
| 7601-15710-G1 | Length 10 mm | In distribution |
| 7611-535300-55 | Length 300 mm | In distribution |
| 7601-05020T | Length 20 mm | In distribution |
| 7601-03530M-G1 | Outer Diameter 3.5 mm | In distribution |
| 7611-B40100-G1 | Outer Diameter 4 mm | In distribution |
| 7611-635100-G1 | Length 100 mm | In distribution |
| 7611-640300 | Outer Diameter 4 mm | In distribution |
| 7601-73520 | Length 20 mm | In distribution |
| 7611-640120-G1 | Outer Diameter 4 mm | In distribution |
| 7601-05040T | Length 40 mm | In distribution |
| 7601-43042 | Width 42 mm | In distribution |
| 7611-63590-G1 | Length 90 mm | In distribution |
| 7601-80047-G1 | Height 4.5 mm | In distribution |
| 7601-03542M | Length 42 mm | In distribution |
| 7601-80025-G1 | Width 5 mm | In distribution |
| 7601-04534M | Length 34 mm | In distribution |
| 7601-14506 | Length 6 mm | In distribution |
| 7601-54080 | Outer Diameter 4 mm | In distribution |
| 7601-15209 | Outer Diameter 5.25 mm | In distribution |
| 7601-15215 | Outer Diameter 5.25 mm | In distribution |
| 7601-635100-G1 | Length 100 mm | In distribution |
| 7611-540500-55S | Outer Diameter 4 mm | In distribution |
| 7611-64060-G1 | Outer Diameter 4 mm | In distribution |
| 7601-80032 | Width 5 mm | In distribution |
| 7601-04528-G1 | Length 28 mm | In distribution |
| 7601-83555B | Outer Diameter 5.5 mm | In distribution |
| 7601-80015-G1 | Width 5 mm | In distribution |
| 7601-14516-G1 | Length 16 mm | In distribution |
| 7601-04034L-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04018M | Length 18 mm | In distribution |
| 7601-03546M | Outer Diameter 3.5 mm | In distribution |
| 7611-54080 | Outer Diameter 4 mm | In distribution |
| 7601-70002 | Length 40 mm | In distribution |
| 7601-80025 | Height 8 mm | In distribution |
| 7601-80012-G1 | Height 6 mm | In distribution |
| 7601-15208-G1 | Length 8 mm | In distribution |
| 7601-03516M | Length 16 mm | In distribution |
| 7601-42432 | Width 32 mm | In distribution |
| 7601-03542 | Outer Diameter 3.5 mm | In distribution |
| 7601-04532-G1 | Length 32 mm | In distribution |
| 7601-63590-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04038M-G1 | Length 38 mm | In distribution |
| 7601-83535E | Outer Diameter 3.5 mm | In distribution |
| 7601-63550 | Outer Diameter 3.5 mm | In distribution |
| 7601-04026L | Length 26 mm | In distribution |
| 7601-42432-G1 | Width 32 mm | In distribution |
| 7601-03534L | Outer Diameter 3.5 mm | In distribution |
| 7601-80009-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-05014M-G1 | Outer Diameter 5 mm | In distribution |
| 7611-64065-G1 | Length 65 mm | In distribution |
| 7601-73520A | Length 20 mm | In distribution |
| 7601-04538M-G1 | Length 38 mm | In distribution |
| 1101-83560A-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-14510-G1 | Length 10 mm | In distribution |
| 7601-80002 | Width 3.5 mm | In distribution |
| 7611-63545-G1 | Length 45 mm | In distribution |
| 7601-15712 | Length 12 mm | In distribution |
| 7601-05038 | Outer Diameter 5 mm | In distribution |
| 7601-15715-G1 | Outer Diameter 5.75 mm | In distribution |
| 7601-04530-G1 | Outer Diameter 4.5 mm | In distribution |
| 7601-80026 | Width 3.5 mm | In distribution |
| 7601-04044 | Outer Diameter 4 mm | In distribution |
| 7601-80045 | Outer Diameter 3.5 mm | In distribution |
| 7601-05046M-G1 | Outer Diameter 5 mm | In distribution |
| 7601-15716-G1 | Outer Diameter 5.75 mm | In distribution |
| 7601-03534M | Length 34 mm | In distribution |
| 7601-80041-G1 | Width 5 mm | In distribution |
| 7601-83535F-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-80024 | Outer Diameter 3.5 mm | In distribution |
| 7601-80023 | Height 4.5 mm | In distribution |
| 7601-80003 | Width 3.5 mm | In distribution |
| 7601-05040-G1 | Length 40 mm | In distribution |
| 7601-04538 | Length 38 mm | In distribution |
| 7601-15213-G1 | Outer Diameter 5.25 mm | In distribution |
| 7601-05012M-G1 | Length 12 mm | In distribution |
| 7601-14509 | Outer Diameter 4.5 mm | In distribution |
| 7601-03526-G1 | Outer Diameter 3.5 mm | In distribution |
| 7601-04028L-G1 | Outer Diameter 4 mm | In distribution |
| 7601-15716 | Length 16 mm | In distribution |
| 7601-14515-G1 | Length 15 mm | In distribution |
| 7601-03516-G1 | Length 16 mm | In distribution |
| 7601-03538M | Outer Diameter 3.5 mm | In distribution |
| 7601-03538L-G1 | Length 38 mm | In distribution |
| 7601-04030M-G1 | Outer Diameter 4 mm | In distribution |
| 7601-04530M-G1 | Length 30 mm | In distribution |
| 7611-635120-G1 | Length 120 mm | In distribution |
| 7601-64025 | Length 25 mm | In distribution |
| 7601-73520S-G1 | Length 20 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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.