Data / Medical devices / Spinal Channeling Instrument, Vertebroplasty
Spinal Channeling Instrument, Vertebroplasty (OCJ): 31 FDA-registered makers in 9 countries
31 establishments in 9 countries are registered with the FDA to make Spinal Channeling Instrument, Vertebroplasty (product code OCJ, Class 1, 21 CFR 888.4540). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 10, 2007, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCJ
- Device class
- 1
- Regulation
- 888.4540
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| China | 5 |
| Italy | 4 |
| India | 3 |
| South Korea | 3 |
| France | 2 |
| Pakistan | 1 |
| Taiwan | 1 |
| Switzerland | 1 |
Makers of Spinal Channeling Instrument, Vertebroplasty
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Izi Medical Products LLC | Owings Mills, MD, United States | Manufacturer | 1 | July 10, 2007 | 0 | 0 | 0 | api.fda.gov |
| Adria SRL. | San Giovanni in Persiceto Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopsybell S.R.L. | MIRANDOLA Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degen Medical | Florence, SC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G21 S.R.I. | San Possidonio Modena, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hicren (Zhejiang) Medtech Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imedicom Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Changmei Medtech Co.,ltd | Changzhou Jiangsu, China | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miing Wei Co., Ltd. | Tsao-Twon Nantou, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseus Fusion Systems LLC | Dallas, TX, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lange Medtech Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecres SPA | VERONA Veneto, Italy | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teknimed SAS | L Union Haute-Garonne, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thiebaud SAS | Paris Ile-de-France, France | Complaint file establishment, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vaupell Midwest Molding and Tooling | Constantine, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 10, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.