Colorado 2™ Spinal System
Plate X09204034 CO2 Interpedclr PLT 34MM
13manufacturers in China registered for this device type
64catalogue numbers in this listing
17510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K984360 |
| Record published | 2015-08-24 |
| 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 4.5 to 600 mm; outer diameter 4.5 to 7.5 mm |
| Distribution end date | 2025-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X8632060 | Outer Diameter 7.0 mm | In distribution |
| 8612230 | Length 30.0 mm | In distribution |
| 8632360 | Length 60.0 mm | In distribution |
| 8634110 | In distribution | |
| X8632345 | Length 45.0 mm | In distribution |
| X8632350 | Length 50.0 mm | In distribution |
| X8632370 | Outer Diameter 7.0 mm | In distribution |
| 8638204 | In distribution | |
| 8638202 | In distribution | |
| 8632355 | Length 55.0 mm | In distribution |
| 8630550 | Length 50.0 mm | In distribution |
| 8638630 | Length 30.0 mm | In distribution |
| X8632340 | Length 40.0 mm | In distribution |
| 8638740 | Length 40.0 mm | In distribution |
| X8632270 | Length 70.0 mm | In distribution |
| 8632350 | Length 50.0 mm | In distribution |
| X8632235 | Outer Diameter 6.5 mm | In distribution |
| 8638525 | Outer Diameter 5.5 mm | In distribution |
| 8615420 | 5.0mm / 5.5mm | In distribution |
| 8674110 | Outer Diameter 6.35 mm | In distribution |
| 8638102 | In distribution | |
| 8638655 | Outer Diameter 6.5 mm | In distribution |
| 8638530 | Outer Diameter 5.5 mm | In distribution |
| 8638645 | Outer Diameter 6.5 mm | In distribution |
| 8638430 | Length 30.0 mm | In distribution |
| 8632270 | Length 70.0 mm | In distribution |
| 8638755 | Outer Diameter 7.5 mm | In distribution |
| 8631104 | In distribution | |
| 8638660 | Length 60.0 mm | In distribution |
| 8638745 | Length 45.0 mm | In distribution |
| 8674111 | In distribution | |
| 8638640 | Length 40.0 mm | In distribution |
| 8613510 | Length 100.0 mm | Withdrawn |
| 8619210 | Withdrawn | |
| 8610655 | Length 55.0 mm | Withdrawn |
| 8613514 | Length 140.0 mm | Withdrawn |
| 8630645 | Length 45.0 mm | Withdrawn |
| 8632070 | Length 70.0 mm | Withdrawn |
| 8613544 | Length 440.0 mm | Withdrawn |
| 8613505 | Length 50.0 mm | Withdrawn |
| 8635405 | Length 4.5 mm | Withdrawn |
| 8638725 | Length 25.0 mm | Withdrawn |
| 8610640 | Length 40.0 mm | Withdrawn |
| 8613507 | Length 70.0 mm | Withdrawn |
| 8619120 | Withdrawn | |
| 8610755 | Length 55.0 mm | Withdrawn |
| 8614100 | Withdrawn | |
| 8619654 | Length 54.0 mm | Withdrawn |
| X09204034 | Length 34.0 mm | Withdrawn |
| 8610525 | Length 25.0 mm | Withdrawn |
| 8612760 | Length 60.0 mm | Withdrawn |
| 8610650 | Length 50.0 mm | Withdrawn |
| 8613560 | Length 600.0 mm | Withdrawn |
| 8638555 | Length 55.0 mm | Withdrawn |
| 8638765 | Length 65.0 mm | Withdrawn |
| 8614120 | Withdrawn | |
| 8612330 | Length 30.0 mm | Withdrawn |
| 8611300 | Withdrawn | |
| 8613538 | Length 380.0 mm | Withdrawn |
| 8632250 | Length 50.0 mm | Withdrawn |
| 8610445 | Length 45.0 mm | Withdrawn |
| X09204042 | Length 42.0 mm | Withdrawn |
| 8664111 | Withdrawn | |
| 8615410 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061915 | 2006-07-25 |
| K043343 | 2004-12-28 |
| K034056 | 2004-04-21 |
| K040072 | 2004-02-12 |
| K033322 | 2003-12-15 |
| K020247 | 2002-07-22 |
| K013962 | 2002-06-20 |
| K020699 | 2002-05-28 |
| K014076 | 2001-12-27 |
| K010720 | 2001-04-11 |
| K010249 | 2001-02-23 |
| K000641 | 2000-12-22 |
| K002399 | 2000-09-27 |
| K001255 | 2000-07-11 |
| K001066 | 2000-06-22 |
| K000453 | 2000-03-10 |
| K000476 | 2000-03-10 |
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.