SlimLine®
115 catalogue numbers from 404-2036, 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
115catalogue 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 | 2019-11-17 |
| Record revised | 2025-11-20 (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 101 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 404-2036 | Length 36.00 mm | In distribution |
| 404-4074 | Length 74.00 mm | In distribution |
| 403-4172 | Length 72.00 mm | In distribution |
| 404-3056 | Length 56.00 mm | In distribution |
| 404-3077 | Length 77.00 mm | In distribution |
| 404-4083 | Length 83.00 mm | In distribution |
| 403-3062 | Length 62.00 mm | In distribution |
| 403-1028 | Length 28.00 mm | In distribution |
| 403-4076 | Length 76.00 mm | In distribution |
| 403-3056 | Length 56.00 mm | In distribution |
| 403-3053 | Length 53.00 mm | In distribution |
| 10403-4080 | Length 80.00 mm | In distribution |
| 403-2036 | Length 36.00 mm | In distribution |
| 10403-4084 | Length 84.00 mm | In distribution |
| 403-2148 | Length 48.00 mm | In distribution |
| 404-4092 | Length 92.00 mm | In distribution |
| 403-4084 | Length 84.00 mm | In distribution |
| 403-1130 | Length 30.00 mm | In distribution |
| 403-3150 | Length 50.00 mm | In distribution |
| 10403-4076 | Length 76.00 mm | In distribution |
| 403-4168 | Length 68.00 mm | In distribution |
| 10403-4184 | Length 84 mm | In distribution |
| 404-3068 | Length 68.00 mm | In distribution |
| 404-2048 | Length 48.00 mm | In distribution |
| 404-2050 | Length 50.00 mm | In distribution |
| 404-4095 | Length 95.00 mm | In distribution |
| 403-1128 | Length 28.00 mm | In distribution |
| 403-3162 | Length 62.00 mm | In distribution |
| 403-4072 | Length 72 mm | In distribution |
| 403-3071 | Length 71.00 mm | In distribution |
| 10403-4068 | Length 68.00 mm | In distribution |
| 404-2052 | Length 52.00 mm | In distribution |
| 10403-4180 | Length 80 mm | In distribution |
| 403-2042 | Length 42.00 mm | In distribution |
| 403-2150 | Length 50.00 mm | In distribution |
| 403-1022 | Length 22.00 mm | In distribution |
| 403-1120 | Length 20.00 mm | In distribution |
| 403-3047 | Length 47.00 mm | In distribution |
| 403-1030 | Length 30.00 mm | In distribution |
| 403-4188 | Length 88.00 mm | In distribution |
| 404-4068 | Length 68.00 mm | In distribution |
| 10403-4188 | Length 88 mm | In distribution |
| 403-2142 | Length 42.00 mm | In distribution |
| 404-4080 | Length 80.00 mm | In distribution |
| 404-2046 | Length 46.00 mm | In distribution |
| 403-2134 | Length 34.00 mm | In distribution |
| 404-3053 | Length 53.00 mm | In distribution |
| 10403-4172 | Length 72 mm | In distribution |
| 403-3153 | Length 53.00 mm | In distribution |
| 403-1034 | Length 34.00 mm | In distribution |
| 403-1026 | Length 26.00 mm | In distribution |
| 403-4088 | Length 88.00 mm | In distribution |
| 403-3159 | Length 59.00 mm | In distribution |
| 403-2034 | Length 34.00 mm | In distribution |
| 403-2038 | Length 38.00 mm | In distribution |
| 403-4192 | Length 92.00 mm | In distribution |
| 403-4180 | Length 80.00 mm | In distribution |
| 404-4101 | Length 101 mm | In distribution |
| 10403-4088 | Length 88.00 mm | In distribution |
| 403-4176 | Length 76.00 mm | In distribution |
| 404-2040 | Length 40.00 mm | In distribution |
| 404-3065 | Length 65.00 mm | In distribution |
| 403-3165 | Length 65.00 mm | In distribution |
| 404-2042 | Length 42.00 mm | In distribution |
| 404-2038 | Length 38 mm | In distribution |
| 403-3171 | Length 71.00 mm | In distribution |
| 403-1024 | Length 24.00 mm | In distribution |
| 403-2046 | Length 46.00 mm | In distribution |
| 403-3065 | Length 65.00 mm | In distribution |
| 403-2044 | Length 44.00 mm | In distribution |
| 403-4080 | Length 80.00 mm | In distribution |
| 404-4098 | Length 98.00 mm | In distribution |
| 403-3059 | Length 59.00 mm | In distribution |
| 404-3062 | Length 62.00 mm | In distribution |
| 403-3050 | Length 50.00 mm | In distribution |
| 403-2048 | Length 48.00 mm | In distribution |
| 404-4086 | Length 86.00 mm | In distribution |
| 404-3071 | Length 72.00 mm | In distribution |
| 404-2054 | Length 54.00 mm | In distribution |
| 403-4184 | Length 84.00 mm | In distribution |
| 403-1122 | Length 22.00 mm | In distribution |
| 403-1124 | Length 24.00 mm | In distribution |
| 403-2144 | Length 44.00 mm | In distribution |
| 403-2138 | Length 38.00 mm | In distribution |
| 404-4071 | Length 71.00 mm | In distribution |
| 403-3147 | Length 47.00 mm | In distribution |
| 403-3068 | Length 68.00 mm | In distribution |
| 403-2040 | Length 40.00 mm | In distribution |
| 404-3059 | Length 59.00 mm | In distribution |
| 403-1132 | Length 32.00 mm | In distribution |
| 403-1020 | Length 20.00 mm | In distribution |
| 404-4077 | Length 77.00 mm | In distribution |
| 403-1134 | Length 34.00 mm | In distribution |
| 404-2034 | Length 34 mm | In distribution |
| 10403-4176 | Length 76 mm | In distribution |
| 10403-4092 | Length 92.00 mm | In distribution |
| 403-2054 | Length 54.00 mm | In distribution |
| 403-1032 | Length 32.00 mm | In distribution |
| 10403-4168 | Length 68 mm | In distribution |
| 403-2146 | Length 46.00 mm | In distribution |
| 404-2044 | Length 44.00 mm | In distribution |
| 403-2052 | Length 52.00 mm | In distribution |
| 404-4089 | Length 89.00 mm | In distribution |
| 10403-4192 | Length 92 mm | In distribution |
| 10403-4072 | Length 72.00 mm | In distribution |
| 403-2140 | Length 40.00 mm | In distribution |
| 403-2136 | Length 36.00 mm | In distribution |
| 403-4092 | Length 92.00 mm | In distribution |
| 403-2152 | Length 52.00 mm | In distribution |
| 403-3156 | Length 56.00 mm | In distribution |
| 403-3168 | Length 68.00 mm | In distribution |
| 404-3074 | Length 74.00 mm | In distribution |
| 403-4068 | Length 68.00 mm | In distribution |
| 403-1126 | Length 26.00 mm | In distribution |
| 403-2154 | Length 54.00 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.