InCompass®
62 catalogue numbers from 2206-8590, 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
62catalogue 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 9.5 to 300 mm; outer diameter 4.5 to 8.5 mm; outer diameter 0.25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2206-8590 | Length 90 mm | In distribution |
| 2211-125 | Outer Diameter 0.25 in | In distribution |
| 2206-4525 | Outer Diameter 4.5 mm | In distribution |
| 2104-9W-EB | 9 MM MOUTH OPENING | In distribution |
| 2206-5530 | Outer Diameter 5.5 mm | In distribution |
| 2105-6530 | Length 30 mm | In distribution |
| 2105-5540 | Outer Diameter 5.5 mm | In distribution |
| 911-300 | Length 300 mm | In distribution |
| 2103-7530 | Length 30 mm | In distribution |
| 2203-8570 | Outer Diameter 8.5 mm | In distribution |
| 2106-5530 | Outer Diameter 5.5 mm | In distribution |
| 2212-20 | Length 20 mm | In distribution |
| 2206-8530 | Outer Diameter 8.5 mm | In distribution |
| 2106-8530 | Outer Diameter 8.5 mm | In distribution |
| 2206-4540 | Outer Diameter 4.5 mm | In distribution |
| 2203-7535 | Outer Diameter 7.5 mm | In distribution |
| 2203-8545 | Outer Diameter 8.5 mm | In distribution |
| 2212-25 | Length 25 mm | In distribution |
| 2105-8550 | Length 50 mm | In distribution |
| 2106-7540 | Outer Diameter 7.5 mm | In distribution |
| 2106-8535 | Outer Diameter 8.5 mm | In distribution |
| 2105-6540 | Length 40 mm | In distribution |
| 9206-075 | Outer Diameter 0.25 in | In distribution |
| 2105-6550 | Length 50 mm | In distribution |
| 2206-8580 | Length 80 mm | In distribution |
| 2103-7545 | Outer Diameter 7.5 mm | In distribution |
| 2106-7535 | Outer Diameter 7.5 mm | In distribution |
| 911-100 | Outer Diameter 5.5 mm | In distribution |
| 2106-8540 | Outer Diameter 8.5 mm | In distribution |
| 2105-7555 | Outer Diameter 7.5 mm | In distribution |
| 2106-4530 | Outer Diameter 4.5 mm | In distribution |
| 2105-7535 | Outer Diameter 7.5 mm | In distribution |
| 2212-70 | Length 70 mm | In distribution |
| 2106-7580 | Outer Diameter 7.5 mm | In distribution |
| 2203-8540 | Length 40 mm | In distribution |
| 2202-95 | Length 9.5 mm | In distribution |
| 2203-5525 | Length 25 mm | In distribution |
| 2105-7560 | Length 60 mm | In distribution |
| 2104-11N-SB | 11 MM MOUTH OPENING | In distribution |
| 2204-11W-SB | 11 MM MOUTH OPENING | In distribution |
| 2201-12 | In distribution | |
| 2103-8540 | Outer Diameter 8.5 mm | In distribution |
| 601-025-6545-S | Length 45 mm | In distribution |
| 2203-7560 | Length 30 mm | In distribution |
| 2211-300 | Length 300 mm | In distribution |
| 2106-7570 | Length 70 mm | In distribution |
| 2203-7540 | Outer Diameter 7.5 mm | In distribution |
| 2102-111 | Length 11 mm | In distribution |
| 2203-7570 | Outer Diameter 7.5 mm | In distribution |
| 2104-11N-EB | 11 MM MOUTH OPENING | In distribution |
| 601-025-6545 | Outer Diameter 6.5 mm | In distribution |
| 9206-050 | Length 50 mm | In distribution |
| 2106-6530 | Outer Diameter 6.5 mm | In distribution |
| 2106-7530 | Outer Diameter 7.5 mm | In distribution |
| 2212-40 | Length 40 mm | In distribution |
| 2202-13 | Length 13 mm | In distribution |
| 2106-4535 | Length 35 mm | In distribution |
| 2206-6535 | Outer Diameter 6.5 mm | In distribution |
| 2206-7555 | Outer Diameter 7.5 mm | In distribution |
| 2203-6540 | Length 40 mm | In distribution |
| 2106-5525 | Outer Diameter 5.5 mm | In distribution |
| 2104-9N-EB | 9 MM MOUTH OPENING | 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.