Trinica®
119 catalogue numbers from 07.01012.003, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
119catalogue 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 | 2025-07-02 (version 8) |
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 20 to 92 mm; angle 16 to 80 °; outer diameter 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07.01012.003 | Length 37 mm | In distribution |
| 07.00101.006 | Length 34 mm | In distribution |
| 07.01008.010 | Length 51 mm | In distribution |
| 07.01008.009 | Angle 16 ° | In distribution |
| 07.01009.009 | Length 49 mm | In distribution |
| 07.01013.006 | Length 32 mm | In distribution |
| 07.01009.007 | Angle 32 ° | In distribution |
| 07.01009.005 | Length 41 mm | In distribution |
| 07.00187.003 | Length 57 mm | In distribution |
| 07.00187.008 | Length 72 mm | In distribution |
| 07.01012.002 | Angle 80 ° | In distribution |
| 07.01012.004 | Length 39 mm | In distribution |
| 07.01014.001 | Outer Diameter 5.5 mm | In distribution |
| 07.00192.001 | Length 22 mm | In distribution |
| 07.00188.003 | Length 74 mm | In distribution |
| 07.00188.009 | Length 92 mm | In distribution |
| 07.00340.001 | Length 22 mm | In distribution |
| 07.01013.001 | Outer Diameter 5.5 mm | In distribution |
| 07.01012.007 | Length 45 mm | In distribution |
| 07.00340.005 | Length 30 mm | In distribution |
| 07.00102.002 | Length 40 mm | In distribution |
| 07.00340.006 | Length 32 mm | In distribution |
| 07.00342.003 | Length 57 mm | In distribution |
| 07.00101.004 | Length 30 mm | In distribution |
| 07.01010.007 | Length 45 mm | In distribution |
| 07.01011.008 | Angle 65 ° | In distribution |
| 07.01013.005 | Length 30 mm | In distribution |
| 07.00342.002 | Length 54 mm | In distribution |
| 07.01011.004 | Length 39 mm | In distribution |
| 07.01009.002 | Length 35 mm | In distribution |
| 07.01010.009 | Angle 48 ° | In distribution |
| 07.00187.004 | Length 60 mm | In distribution |
| 07.01009.006 | Angle 32 ° | In distribution |
| 07.01012.010 | Angle 80 ° | In distribution |
| 07.00341.001 | Length 38 mm | In distribution |
| 07.00102.006 | Length 48 mm | In distribution |
| 07.00187.001 | Length 51 mm | In distribution |
| 07.00342.001 | Length 51 mm | In distribution |
| 07.00102.007 | Length 50 mm | In distribution |
| 07.01013.002 | Length 24 mm | In distribution |
| 07.01014.003 | Length 26 mm | In distribution |
| 07.01011.010 | Length 51 mm | In distribution |
| 07.00101.002 | Length 26 mm | In distribution |
| 07.01010.003 | Angle 48 ° | In distribution |
| 07.00340.003 | Length 26 mm | In distribution |
| 07.00101.003 | Length 28 mm | In distribution |
| 07.00188.007 | Length 86 mm | In distribution |
| 07.01011.006 | Angle 65 ° | In distribution |
| 07.01014.004 | Length 28 mm | In distribution |
| 07.00188.008 | Length 89 mm | In distribution |
| 07.00341.005 | Length 46 mm | In distribution |
| 07.01014.007 | Length 34 mm | In distribution |
| 07.00341.007 | Length 50 mm | In distribution |
| 07.01008.007 | Angle 16 ° | In distribution |
| 07.01013.003 | Length 26 mm | In distribution |
| 07.01010.002 | Angle 48 ° | In distribution |
| 07.00102.001 | Length 38 mm | In distribution |
| 07.00102.009 | Length 54 mm | In distribution |
| 07.00342.008 | Length 72 mm | In distribution |
| 07.01012.009 | Angle 80 ° | In distribution |
| 07.01010.005 | Angle 48 ° | In distribution |
| 07.01010.006 | Length 43 mm | In distribution |
| 07.01009.010 | Length 51 mm | In distribution |
| 07.01008.005 | Angle 16 ° | In distribution |
| 07.00102.003 | Length 42 mm | In distribution |
| 07.00342.007 | Length 69 mm | In distribution |
| 07.00340.009 | Length 20 mm | In distribution |
| 07.01013.004 | Outer Diameter 5.5 mm | In distribution |
| 07.00342.005 | Length 63 mm | In distribution |
| 07.00187.007 | Length 69 mm | In distribution |
| 07.01013.007 | Outer Diameter 5.5 mm | In distribution |
| 07.01012.005 | Angle 80 ° | In distribution |
| 07.01010.008 | Angle 48 ° | In distribution |
| 07.01008.002 | Length 35 mm | In distribution |
| 07.01009.003 | Length 37 mm | In distribution |
| 07.00342.004 | Length 60 mm | In distribution |
| 07.00168.001 | In distribution | |
| 07.00188.005 | Length 80 mm | In distribution |
| 07.00102.005 | Length 46 mm | In distribution |
| 07.01011.003 | Length 37 mm | In distribution |
| 07.00342.006 | Length 66 mm | In distribution |
| 07.00340.004 | Length 28 mm | In distribution |
| 07.00188.002 | Length 71 mm | In distribution |
| 07.00101.007 | Length 36 mm | In distribution |
| 07.01014.006 | Length 32 mm | In distribution |
| 07.01014.005 | Length 30 mm | In distribution |
| 07.01010.004 | Length 39 mm | In distribution |
| 07.00101.001 | Length 24 mm | In distribution |
| 07.00188.004 | Length 77 mm | In distribution |
| 07.01011.009 | Angle 65 ° | In distribution |
| 07.01010.010 | Length 51 mm | In distribution |
| 07.01009.004 | Length 39 mm | In distribution |
| 07.01008.003 | Length 37 mm | In distribution |
| 07.00188.001 | Length 68 mm | In distribution |
| 07.01014.002 | Length 24 mm | In distribution |
| 07.00340.002 | Length 24 mm | In distribution |
| 07.01008.006 | Angle 16 ° | In distribution |
| 07.00341.008 | Length 52 mm | In distribution |
| 07.00341.003 | Length 42 mm | In distribution |
| 07.01011.002 | Angle 65 ° | In distribution |
| 07.01008.008 | Angle 16 ° | In distribution |
| 07.00341.006 | Length 48 mm | In distribution |
| 07.00187.005 | Length 63 mm | In distribution |
| 07.00188.006 | Length 83 mm | In distribution |
| 07.00187.002 | Length 54 mm | In distribution |
| 07.01009.008 | Length 47 mm | In distribution |
| 07.00102.008 | Length 52 mm | In distribution |
| 07.00341.004 | Length 44 mm | In distribution |
| 07.01008.004 | Length 39 mm | In distribution |
| 07.00341.009 | Length 36 mm | In distribution |
| 07.00187.006 | Length 66 mm | In distribution |
| 07.01011.007 | Length 45 mm | In distribution |
| 07.00102.004 | Length 44 mm | In distribution |
| 07.00101.005 | Length 32 mm | In distribution |
| 07.01012.008 | Angle 80 ° | In distribution |
| 07.01012.006 | Angle 80 ° | In distribution |
| 07.01011.005 | Angle 65 ° | In distribution |
| 07.00341.002 | Length 40 mm | In distribution |
| 07.00340.007 | Length 34 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 |
|---|---|
| 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.