Colorado 2™ Spinal System
Plate X09204032 CO2 Interpedclr PLT 32MM
11manufacturers in China registered for this device type
58catalogue numbers in this listing
44510(k) clearances naming this product 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K991031 |
| Record published | 2015-07-31 |
| Record revised | 2025-12-23 (version 7) |
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 25 to 360 mm; outer diameter 4.5 to 7.5 mm |
| Distribution end date | 2025-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X8632065 | Outer Diameter 7.0 mm | In distribution |
| X8632070 | Outer Diameter 7.0 mm | In distribution |
| 8638435 | Outer Diameter 4.5 mm | In distribution |
| 8638220 | In distribution | |
| X8632355 | Outer Diameter 7.0 mm | In distribution |
| 8638735 | Length 35.0 mm | In distribution |
| 8631102 | In distribution | |
| 8632245 | Length 45.0 mm | In distribution |
| 8634111 | In distribution | |
| 8632060 | Length 60.0 mm | In distribution |
| 8612255 | Length 55.0 mm | In distribution |
| X8632335 | Outer Diameter 7.0 mm | In distribution |
| 8638210 | In distribution | |
| X8632240 | Outer Diameter 6.5 mm | In distribution |
| 8631300 | In distribution | |
| 8611104 | In distribution | |
| 8611204 | In distribution | |
| 8632075 | Length 75.0 mm | In distribution |
| 8632330 | Length 30.0 mm | In distribution |
| X8632055 | Outer Diameter 7.0 mm | In distribution |
| 8632260 | Length 60.0 mm | In distribution |
| 8632335 | Length 35.0 mm | In distribution |
| 8638540 | Outer Diameter 5.5 mm | In distribution |
| 8612055 | Length 55.0 mm | In distribution |
| 8610540 | Length 40.0 mm | In distribution |
| X8632260 | Length 60.0 mm | In distribution |
| X8632365 | Length 65.0 mm | In distribution |
| 8634200 | In distribution | |
| 8613522 | Length 220.0 mm | Withdrawn |
| 8619220 | Withdrawn | |
| 8612075 | Length 75.0 mm | Withdrawn |
| 8635430 | Withdrawn | |
| 8612355 | Length 55.0 mm | Withdrawn |
| 8638760 | Length 60.0 mm | Withdrawn |
| 8614200 | Withdrawn | |
| X09204032 | Length 32.0 mm | Withdrawn |
| 8612350 | Length 50.0 mm | Withdrawn |
| 8632760 | Length 60.0 mm | Withdrawn |
| 8610550 | Length 50.0 mm | Withdrawn |
| 8613526 | Length 260.0 mm | Withdrawn |
| 8612080 | Length 80.0 mm | Withdrawn |
| 8610750 | Length 50.0 mm | Withdrawn |
| 8664110 | Outer Diameter 6.35 mm | Withdrawn |
| 8613536 | Length 360.0 mm | Withdrawn |
| 8610530 | Length 30.0 mm | Withdrawn |
| 8613524 | Length 240.0 mm | Withdrawn |
| X09204036 | Length 36.0 mm | Withdrawn |
| 8610435 | Length 35.0 mm | Withdrawn |
| 8613516 | Length 160.0 mm | Withdrawn |
| 8610535 | Length 35.0 mm | Withdrawn |
| 8613520 | Length 200.0 mm | Withdrawn |
| 8638625 | Outer Diameter 6.5 mm | Withdrawn |
| 8632365 | Length 65.0 mm | Withdrawn |
| 8613530 | Length 300.0 mm | Withdrawn |
| 8610745 | Length 45.0 mm | Withdrawn |
| 8632065 | Length 65.0 mm | Withdrawn |
| 8612340 | Length 40.0 mm | Withdrawn |
| 8615440 | 5.0mm/7.0mm | Withdrawn |
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 |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Warsaw Orthopedic, Inc. | 510(k) number | 2007-09-10 | Not classified | Process control | Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced. | 2,569 | 2009-07-14 |
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.