Indus®
Indus Invue MAX Symmetrical ACP, 4 Level, 109mm
14manufacturers in China registered for this device type
181catalogue numbers in this listing
3510(k) clearances naming this product 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 | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K093776 |
| Record published | 2016-04-15 |
| Record revised | 2025-11-20 (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 |
| Sizes | Length 5 to 109 mm; width 16 to 16.5 mm; outer diameter 4 to 4.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM71026-11 | Width 16.5 mm | In distribution |
| 01-71005-09 | Width 16 mm | In distribution |
| IM71036-07 | Length 72 mm | In distribution |
| 01-71004-49 | Length 49 mm | In distribution |
| 01-71005-08 | Width 16 mm | In distribution |
| IM71045-02 | Length 73 mm | In distribution |
| IM71019-01 | Width 16.5 mm | In distribution |
| IM71026-10 | Length 55 mm | In distribution |
| IM71016-01 | Length 12 mm | In distribution |
| IM71036-01 | Width 16.5 mm | In distribution |
| 01-71004-41 | Width 16.5 mm | In distribution |
| 01-71006-60 | Width 16.5 mm | In distribution |
| IM71058-03 | Length 16 mm | In distribution |
| 01-71014-66 | Width 16.5 mm | In distribution |
| 01-71015-97 | Width 16.5 mm | In distribution |
| 01-71007-73 | Width 16.5 mm | In distribution |
| 01-71013-53 | Length 55 mm | In distribution |
| IM71045-03 | Width 16.5 mm | In distribution |
| IM71045-06 | Length 89 mm | In distribution |
| 01-71014-54 | Length 54 mm | In distribution |
| 01-71012-31 | Width 16.5 mm | In distribution |
| 01-71004-33 | Width 16.5 mm | In distribution |
| 01-71002-17 | Length 17 mm | In distribution |
| 01-71013-43 | Width 16.5 mm | In distribution |
| 11-70101-06 | In distribution | |
| 01-71015-85 | Length 85 mm | In distribution |
| 01-71006-54 | Width 16.5 mm | In distribution |
| IM71016-02 | Length 14 mm | In distribution |
| IM71026-02 | Length 39 mm | In distribution |
| 11-70101-12 | In distribution | |
| IM71036-11 | Width 16.5 mm | In distribution |
| 01-71004-55 | Length 55 mm | In distribution |
| 01-71005-10 | Width 16 mm | In distribution |
| 01-71005-11 | Width 16 mm | In distribution |
| IM71045-04 | Width 16.5 mm | In distribution |
| 11-70101-08 | In distribution | |
| 01-71013-55 | Width 16.5 mm | In distribution |
| 01-71004-47 | Length 47 mm | In distribution |
| 01-71013-41 | Length 41 mm | In distribution |
| 01-71004-45 | Width 16.5 mm | In distribution |
| 01-71003 | Length 43 mm | In distribution |
| IM71058-01 | Length 12 mm | In distribution |
| 01-71013-33 | Length 33 mm | In distribution |
| IM71045-10 | Width 16.5 mm | In distribution |
| 01-71015-93 | Length 93 mm | In distribution |
| 01-71012-27 | Width 16.5 mm | In distribution |
| 01-71004-37 | Width 16.5 mm | In distribution |
| 01-71002-21 | Width 16.5 mm | In distribution |
| 01-71007-101 | Length 101 mm | In distribution |
| IM71019-06 | Width 16.5 mm | In distribution |
| IM71057-03 | Length 16 mm | In distribution |
| 01-71004-53 | Length 53 mm | In distribution |
| 01-71005-12 | Length 12 mm | In distribution |
| IM71057-02 | Outer Diameter 4 mm | In distribution |
| IM71057-01 | Length 12 mm | In distribution |
| IM71036-06 | Width 16.5 mm | In distribution |
| IM71019-07 | Length 35 mm | In distribution |
| 01-71002-23 | Width 16.5 mm | In distribution |
| IM71058-02 | Length 14 mm | In distribution |
| 01-71005-07 | Width 16 mm | In distribution |
| 01-71002-29 | Length 29 mm | In distribution |
| 01-71014-78 | Length 78 mm | In distribution |
| 01-71015-61 | Width 16.5 mm | In distribution |
| 11-70117-08 | In distribution | |
| 01-71002-19 | Width 16.5 mm | In distribution |
| 01-71002-35 | Width 16.5 mm | In distribution |
| IM71019-05 | Width 16.5 mm | In distribution |
| 01-71015-65 | Length 65 mm | In distribution |
| 01-71006-69 | Length 69 mm | In distribution |
| 01-71015-109 | Length 109 mm | In distribution |
| IM71026-12 | Width 16.5 mm | In distribution |
| 01-71004-43 | Length 43 mm | In distribution |
| 01-71006-66 | Length 66 mm | In distribution |
| 01-71015-77 | Width 16.5 mm | In distribution |
| 01-71013-49 | Length 49 mm | In distribution |
| IM71019-09 | Width 16.5 mm | In distribution |
| 11-70101-11 | In distribution | |
| 11-70101-10 | In distribution | |
| 01-71008-16 | Length 16 mm | In distribution |
| 01-71014-51 | Length 51 mm | In distribution |
| 01-71014-72 | Width 16.5 mm | In distribution |
| IM71059-02 | Outer Diameter 4.2 mm | In distribution |
| 01-71012-25 | Length 25 mm | In distribution |
| 01-71007-77 | Length 77 mm | In distribution |
| 01-71014-69 | Width 16.5 mm | In distribution |
| 01-71013-45 | Width 16.5 mm | In distribution |
| 01-71007-109 | Width 16.5 mm | In distribution |
| 01-71015-73 | Length 73 mm | In distribution |
| IM71036-09 | Length 78 mm | In distribution |
| IM71016-03 | Outer Diameter 4.5 mm | In distribution |
| IM71059-01 | Length 12 mm | In distribution |
| 01-71015-89 | Width 16.5 mm | In distribution |
| 01-71002-33 | Length 33 mm | In distribution |
| IM71045-05 | Width 16.5 mm | In distribution |
| IM71026-07 | Length 49 mm | In distribution |
| 01-71012-23 | Width 16.5 mm | In distribution |
| IM71045-07 | Width 16.5 mm | In distribution |
| 01-71007-105 | Length 105 mm | In distribution |
| 01-71012-19 | Length 19 mm | In distribution |
| 01-71008-12 | Length 12 mm | In distribution |
| 01-71006-51 | Length 51 mm | In distribution |
| 01-71015-105 | Width 16.5 mm | In distribution |
| IM71059-03 | Length 16 mm | In distribution |
| 11-70117-05 | In distribution | |
| IM71019-02 | Width 16.5 mm | In distribution |
| 01-71014-48 | Width 16.5 mm | In distribution |
| IM71026-04 | Width 16.5 mm | In distribution |
| 01-71012-33 | Width 16.5 mm | In distribution |
| 11-70117-07 | In distribution | |
| IM71019-04 | Width 16.5 mm | In distribution |
| 01-71014-60 | Width 16.5 mm | In distribution |
| 01-71013-47 | Width 16.5 mm | In distribution |
| IM71013-01 | Length 12 mm | In distribution |
| 01-71012-17 | Length 17 mm | In distribution |
| IM71019-10 | Width 16.5 mm | In distribution |
| 01-71007-93 | Length 93 mm | In distribution |
| 01-71002-31 | Length 31 mm | In distribution |
| IM71045-09 | Width 16.5 mm | In distribution |
| 01-71007-89 | Length 89 mm | In distribution |
| 01-71014-63 | Width 16.5 mm | In distribution |
| 11-70101-09 | In distribution | |
| 01-71004-35 | Length 35 mm | In distribution |
| IM71036-03 | Width 16.5 mm | In distribution |
| IM71045-08 | Width 16.5 mm | In distribution |
| 01-71006-63 | Length 63 mm | In distribution |
| IM71036-10 | Length 51 mm | In distribution |
| 01-71004-39 | Length 39 mm | In distribution |
| 01-71006-72 | Width 16.5 mm | In distribution |
| 01-71015-81 | Width 16.5 mm | In distribution |
| 01-71013-35 | Length 35 mm | In distribution |
| IM71026-01 | Length 37 mm | In distribution |
| 11-70117-12 | In distribution | |
| IM71026-08 | Width 16.5 mm | In distribution |
| 11-70117-09 | In distribution | |
| 01-71012-35 | Width 16.5 mm | In distribution |
| IM71013-03 | Outer Diameter 4 mm | In distribution |
| 01-71002-27 | Width 16.5 mm | In distribution |
| IM71045-01 | Length 69 mm | In distribution |
| IM71045-13 | Length 61 mm | In distribution |
| 01-71002-25 | Width 16.5 mm | In distribution |
| 11-70117-06 | In distribution | |
| 01-71013-37 | Length 37 mm | In distribution |
| IM71019-03 | Width 16.5 mm | In distribution |
| 11-70101-07 | In distribution | |
| 01-71013-51 | Length 51 mm | In distribution |
| 11-70117-10 | In distribution | |
| 01-71007-65 | Width 16.5 mm | In distribution |
| 01-71005-05 | Length 5 mm | In distribution |
| 01-71006-75 | Length 75 mm | In distribution |
| IM71045-11 | Length 109 mm | In distribution |
| IM71036-02 | Length 57 mm | In distribution |
| IM71045-12 | Width 16.5 mm | In distribution |
| 01-71007-85 | Width 16.5 mm | In distribution |
| 01-71007-81 | Width 16.5 mm | In distribution |
| 01-71007-69 | Width 16.5 mm | In distribution |
| IM71026-06 | Length 47 mm | In distribution |
| 01-71014-57 | Length 57 mm | In distribution |
| IM71019-08 | Width 16.5 mm | In distribution |
| 01-71013-39 | Length 39 mm | In distribution |
| IM71036-04 | Width 16.5 mm | In distribution |
| IM71026-09 | Length 53 mm | In distribution |
| 01-71005-06 | Width 16 mm | In distribution |
| 01-71006-57 | Width 16.5 mm | In distribution |
| IM71026-03 | Length 41 mm | In distribution |
| 01-71004-51 | Width 16.5 mm | In distribution |
| 01-71006-78 | Length 78 mm | In distribution |
| 01-71015-101 | Length 101 mm | In distribution |
| 01-71008-14 | Length 14 mm | In distribution |
| 11-70101-05 | In distribution | |
| 01-71015-69 | Width 16.5 mm | In distribution |
| IM71036-05 | Length 66 mm | In distribution |
| 01-71006-48 | Length 48 mm | In distribution |
| 01-71012-29 | Width 16.5 mm | In distribution |
| 01-71007-61 | Width 16.5 mm | In distribution |
| 11-70117-11 | In distribution | |
| 01-71007-97 | Width 16.5 mm | In distribution |
| 01-71014-75 | Width 16.5 mm | In distribution |
| 01-71012-21 | Width 16.5 mm | In distribution |
| IM71026-05 | Width 16.5 mm | In distribution |
| IM71036-08 | Width 16.5 mm | In distribution |
| IM71013-02 | Outer Diameter 4 mm | In distribution |
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 |
|---|---|
| K121060 | 2012-07-03 |
| K093776 | 2010-03-26 |
| K073232 | 2008-02-20 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Packaging process control | Mismarked and unmarked screws | 993 | 2018-09-06 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Packaging process control | Mismarked and unmarked screws | 922 | 2018-09-06 |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Packaging process control | Mismarked and unmarked screws | 2018-09-06 | |
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2013-11-20 | Class II | Packaging process control | Mismarked and unmarked screws | 2018-09-06 |
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.