inViZia®
inVizia® Double Barrel Drill Guide, Variable
14manufacturers in China registered for this device type
53catalogue numbers in this listing
7510(k) clearances naming this product code
1recall
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 | Zimmer Spine, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-09-24 |
| Record revised | 2025-01-03 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 18 to 92 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07.01615.001 | Length 18 mm | In distribution |
| 07.01616.008 | Length 48 mm | In distribution |
| 07.01618.007 | Length 92 mm | In distribution |
| 07.01616.007 | Length 46 mm | In distribution |
| 07.01610.005 | In distribution | |
| 07.01618.004 | Length 80 mm | In distribution |
| 07.01610.013 | In distribution | |
| 07.01616.011 | Length 54 mm | In distribution |
| 07.01586.001 | In distribution | |
| 07.01616.001 | Length 34 mm | In distribution |
| 07.01610.011 | In distribution | |
| 07.01616.003 | Length 38 mm | In distribution |
| 07.01618.001 | Length 68 mm | In distribution |
| 07.01610.009 | In distribution | |
| 07.01615.009 | Length 34 mm | In distribution |
| 07.01616.006 | Length 44 mm | In distribution |
| 07.01616.005 | Length 42 mm | In distribution |
| 07.01615.003 | Length 22 mm | In distribution |
| 07.01617.009 | Length 72 mm | In distribution |
| 07.01615.008 | Length 32 mm | In distribution |
| 07.01617.001 | Length 48 mm | In distribution |
| 07.01617.004 | Length 57 mm | In distribution |
| 07.01617.002 | Length 51 mm | In distribution |
| 07.01615.002 | Length 20 mm | In distribution |
| 07.01610.008 | In distribution | |
| 07.01615.006 | Length 28 mm | In distribution |
| 07.01610.014 | In distribution | |
| 07.01610.002 | In distribution | |
| 07.01610.010 | In distribution | |
| 07.01616.010 | Length 52 mm | In distribution |
| 07.01615.005 | Length 26 mm | In distribution |
| 07.01617.006 | Length 63 mm | In distribution |
| 07.01616.002 | Length 36 mm | In distribution |
| 07.01617.003 | Length 54 mm | In distribution |
| 07.01618.005 | Length 84 mm | In distribution |
| 07.01616.009 | Length 50 mm | In distribution |
| 07.01617.008 | Length 69 mm | In distribution |
| 07.01618.003 | Length 76 mm | In distribution |
| 07.01617.005 | Length 60 mm | In distribution |
| 07.01610.001 | In distribution | |
| 07.01617.007 | Length 66 mm | In distribution |
| 07.01610.015 | In distribution | |
| 07.01610.004 | In distribution | |
| 07.00896.701 | In distribution | |
| 07.01610.003 | In distribution | |
| 07.01618.006 | Length 88 mm | In distribution |
| 07.01615.007 | Length 30 mm | In distribution |
| 07.01615.004 | Length 24 mm | In distribution |
| 07.01610.007 | In distribution | |
| 07.01616.004 | Length 40 mm | In distribution |
| 07.01618.002 | Length 72 mm | In distribution |
| 07.01610.006 | In distribution | |
| 07.01610.012 | 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 |
|---|---|
| K143626 | 2015-03-20 |
| K141500 | 2014-09-23 |
| K140611 | 2014-05-21 |
| K132012 | 2013-08-29 |
| K122733 | 2012-12-07 |
| K111796 | 2011-10-27 |
| K061353 | 2006-08-30 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-08-24 | Not classified | Other | To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentati | 82 sets | 2005-11-03 |
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.