InCompass®
69 catalogue numbers from 9206-300, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
69catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Zimmer Spine, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 11 to 600 mm; outer diameter 4.5 to 8.5 mm; outer diameter 0.25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9206-300 | Outer Diameter 0.25 in | In distribution |
| 2105-5535 | Outer Diameter 5.5 mm | In distribution |
| 9206-125 | Outer Diameter 0.25 in | In distribution |
| 2105-4545 | Length 45 mm | In distribution |
| 2206-5540 | Outer Diameter 5.5 mm | In distribution |
| 2105-5555 | Outer Diameter 5.5 mm | In distribution |
| 2104-9N-SB | 9 MM MOUTH OPENING | In distribution |
| 2105-4525 | Outer Diameter 4.5 mm | In distribution |
| 2103-5535 | Length 35 mm | In distribution |
| 2106-8545 | Length 45 mm | In distribution |
| 2106-6540 | Length 40 mm | In distribution |
| 2202-30 | Length 30 mm | In distribution |
| 2211-450 | Length 450 mm | In distribution |
| 2106-5540 | Outer Diameter 5.5 mm | In distribution |
| 810-100 | Outer Diameter 0.25 in | In distribution |
| 2104-11W-SB | 11 MM MOUTH OPENING | In distribution |
| 2106-5535 | Outer Diameter 5.5 mm | In distribution |
| 2105-7550 | Outer Diameter 7.5 mm | In distribution |
| 2105-5545 | Length 45 mm | In distribution |
| 2105-8560 | Length 60 mm | In distribution |
| 2104-7N-SB | 7 MM MOUTH OPENING | In distribution |
| 2201-2 | In distribution | |
| 2203-7580 | Length 80 mm | In distribution |
| 2105-4530 | Outer Diameter 4.5 mm | In distribution |
| 2103-4540 | Length 40 mm | In distribution |
| 2105-7545 | Outer Diameter 7.5 mm | In distribution |
| 2105-4540 | Outer Diameter 4.5 mm | In distribution |
| 2103-6550 | Outer Diameter 6.5 mm | In distribution |
| 2104-P85-SB | 8.5 MM MOUTH OPENING | In distribution |
| 2203-6545 | Length 45 mm | In distribution |
| 2103-5545 | Outer Diameter 5.5 mm | In distribution |
| 2203-7555 | Length 55 mm | In distribution |
| 2203-4530 | Outer Diameter 4.5 mm | In distribution |
| 2212-30 | Length 30 mm | In distribution |
| 2103-8535 | Outer Diameter 8.5 mm | In distribution |
| 2106-6550 | Length 50 mm | In distribution |
| 2206-7535 | Length 35 mm | In distribution |
| 2203-6535 | Length 35 mm | In distribution |
| 2105-5525 | Length 25 mm | In distribution |
| 2105-5530 | Length 30 mm | In distribution |
| 2202-111 | Length 11 mm | In distribution |
| 810-075 | Length 75 mm | In distribution |
| 2206-8545 | Outer Diameter 8.5 mm | In distribution |
| 2212-50 | Length 50 mm | In distribution |
| 2206-6545 | Length 45 mm | In distribution |
| 2206-4530 | Outer Diameter 4.5 mm | In distribution |
| 2105-6560 | Length 60 mm | In distribution |
| 2203-4540 | Outer Diameter 4.5 mm | In distribution |
| 810-300 | Length 300 mm | In distribution |
| 2102-30 | Length 30 mm | In distribution |
| 2203-7590 | Length 90 mm | In distribution |
| 2105-6555 | Length 55 mm | In distribution |
| 2106-6545 | Length 45 mm | In distribution |
| 2206-8540 | Length 40 mm | In distribution |
| 2206-6550 | Length 50 mm | In distribution |
| 2105-4535 | Length 35 mm | In distribution |
| 2103-5525 | Outer Diameter 5.5 mm | In distribution |
| 911-050 | Length 50 mm | In distribution |
| 2206-7570 | Outer Diameter 7.5 mm | In distribution |
| 2211-100 | Length 100 mm | In distribution |
| 2103-4530 | Outer Diameter 4.5 mm | In distribution |
| 810-600 | Length 600 mm | In distribution |
| 2105-8535 | Length 35 mm | In distribution |
| 2203-8530 | Length 30 mm | In distribution |
| 2206-5535 | Outer Diameter 5.5 mm | In distribution |
| 2106-7590 | Length 90 mm | In distribution |
| 810-050 | Outer Diameter 0.25 in | In distribution |
| 601-025-7530 | Length 30 mm | In distribution |
| 2104-UL-SB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133556 | 2014-06-02 |
| K041925 | 2004-09-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-02-03 | Class II | Under Investigation by firm | Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual. | 15,753 | 2016-10-11 |
| 2006-10-05 | Not classified | Other | Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing. | 159 | 2007-10-29 |
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.