Isola
ANTERIOR ISOLA SPINE SYSTEM CLOSED SCREW 4.75 x 4.75 x 70mm
14manufacturers in China registered for this device type
112catalogue numbers in this listing
10510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K980485 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
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 |
| Distribution end date | 2024-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500022 | In distribution | |
| 500023 | In distribution | |
| 203007R | In distribution | |
| 5003191SR | Withdrawn | |
| 50113540 | Withdrawn | |
| 5003200SL | Withdrawn | |
| 5000224R | Withdrawn | |
| 50001970 | Withdrawn | |
| 50011925 | Withdrawn | |
| 50001955 | Withdrawn | |
| 5003108L | Withdrawn | |
| 50102430 | Withdrawn | |
| 50001950 | Withdrawn | |
| 50112445 | Withdrawn | |
| 52201616 | Withdrawn | |
| 50011955 | Withdrawn | |
| 50001925 | Withdrawn | |
| 223028 | Withdrawn | |
| 5203130 | Withdrawn | |
| 50001351M | Withdrawn | |
| 223037 | Withdrawn | |
| 50011920 | Withdrawn | |
| 50201618 | Withdrawn | |
| 50001945 | Withdrawn | |
| 50011970 | Withdrawn | |
| 5203123 | Withdrawn | |
| 5000234L | Withdrawn | |
| 50102850 | Withdrawn | |
| 5000611 | Withdrawn | |
| 5003113 | Withdrawn | |
| 50001940 | Withdrawn | |
| 2030351 | Withdrawn | |
| 50002440 | Withdrawn | |
| 50011965 | Withdrawn | |
| 50112450 | Withdrawn | |
| 50111925 | Withdrawn | |
| 5003435 | Withdrawn | |
| 50103240 | Withdrawn | |
| 203080 | Withdrawn | |
| 50112430 | Withdrawn | |
| 52201618 | Withdrawn | |
| 50103260 | Withdrawn | |
| 500388R | Withdrawn | |
| 520009SS | Withdrawn | |
| 5003211SR | Withdrawn | |
| 50113245 | Withdrawn | |
| 5003101SL | Withdrawn | |
| 5203120 | Withdrawn | |
| 50011935 | Withdrawn | |
| 5203104L | Withdrawn | |
| 2030761 | Withdrawn | |
| 50112440 | Withdrawn | |
| 2030540 | Withdrawn | |
| 50011950 | Withdrawn | |
| 5003105 | Withdrawn | |
| 50113260 | Withdrawn | |
| 223035 | Withdrawn | |
| 5003100 | Withdrawn | |
| 500380 | Withdrawn | |
| 5003124L | Withdrawn | |
| 50103550 | Withdrawn | |
| 50002820 | Withdrawn | |
| 50102845 | Withdrawn | |
| 500390 | Withdrawn | |
| 50001960 | Withdrawn | |
| 50011960 | Withdrawn | |
| 5000425 | Withdrawn | |
| 50102435 | Withdrawn | |
| 50113545 | Withdrawn | |
| 50011930 | Withdrawn | |
| 50113550 | Withdrawn | |
| 50102440 | Withdrawn | |
| 2030250 | Withdrawn | |
| 203000 | Withdrawn | |
| 500058DR | Withdrawn | |
| 50011940 | Withdrawn | |
| 5003220SL | Withdrawn | |
| 5000204R | Withdrawn | |
| 50113235 | Withdrawn | |
| 50103245 | Withdrawn | |
| 5000204L | Withdrawn | |
| 50001930 | Withdrawn | |
| 22301000 | Withdrawn | |
| 50101930 | Withdrawn | |
| 500058DL | Withdrawn | |
| 520048ANL | Withdrawn | |
| 50002435 | Withdrawn | |
| 50111935 | Withdrawn | |
| 50001935 | Withdrawn | |
| 50001522 | Withdrawn | |
| 50113240 | Withdrawn | |
| 52201620 | Withdrawn | |
| 50001920 | Withdrawn | |
| 50011945 | Withdrawn | |
| 50111940 | Withdrawn | |
| 2230050 | Withdrawn | |
| 50101935 | Withdrawn | |
| 50112835 | Withdrawn | |
| 50013220 | Withdrawn | |
| 5003181SL | Withdrawn | |
| 5000210 | Withdrawn | |
| 5003210SL | Withdrawn | |
| 5003110SR | Withdrawn | |
| 50101925 | Withdrawn | |
| 50112435 | Withdrawn | |
| 50001965 | Withdrawn | |
| 5003425 | Withdrawn | |
| 5203135 | Withdrawn | |
| 50111930 | Withdrawn | |
| 30041524 | Withdrawn | |
| 5003110SL | Withdrawn | |
| 50102445 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100070 | 2010-02-04 |
| K082273 | 2008-09-10 |
| K080191 | 2008-04-02 |
| K072546 | 2007-10-05 |
| K070994 | 2007-05-09 |
| K052546 | 2006-02-03 |
| K052552 | 2005-10-13 |
| K042544 | 2004-11-23 |
| K041205 | 2004-08-17 |
| K040655 | 2004-06-02 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 1 unit | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 14 units | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 6 units | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 9 units | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 12 units | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 9 units | 2017-09-18 |
| 2016-10-12 | Class II | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | 21 units | 2017-09-18 |
| 2015-11-20 | Class II | Device Design | Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length | 16 devices | 2017-07-03 |
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.