Data / Medical devices / Prosthesis, Intervertebral Disc
Prosthesis, Intervertebral Disc (MJO): 62 FDA-registered makers in 4 countries
62 establishments in 4 countries are registered with the FDA to make Prosthesis, Intervertebral Disc (product code MJO, Class 3). 15 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJO
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 49 |
| France | 5 |
| Germany | 5 |
| Switzerland | 3 |
Makers of Prosthesis, Intervertebral Disc
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 |
|---|---|---|---|---|---|---|---|---|
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 3 | 2 | 0 | api.fda.gov | |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Manufacturer for export | 0 | 3 | 0 | 0 | api.fda.gov | |
| Centinel Spine, LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 2 | 4 | 0 | api.fda.gov | |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Manufacturer for export | 0 | 2 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 0 | 2 | 1 | 0 | api.fda.gov | |
| Companion Spine | Merignac Gironde, France | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Spineart SA | Plan-les-Ouates, Switzerland | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Synergy Spine Solutions Inc | Louisville, CO, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpes CN SAS | Reignier-Esery Haute-Savoie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bricon Technology GmbH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&A Tool Engineering, Inc. Auburn Plant | Auburn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cep Bio-Coat, LLC | Farmington Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CERAMTEC GmbH Medical Products Division | PLOCHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Christian Diener GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot America, Inc. | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot GMBH | Rostock Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dymicron | Orem, UT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fruh Packaging Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hammill MFG. Co. | Maumee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Sandy, UT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K2M, Inc. | Leesburg, VA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ngage Medical Manufacturing | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Rockaway, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Orthopedic Technologies Inc. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Clean Injection | PESCHADOIRES Puy-de-Dome, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Chaumont S.A.S. | CHAUMONT Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westwood Precision LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.