Data / Medical devices / Growing Rod System / United States
FDA-registered makers of Growing Rod System in the United States: 27 establishments
27 establishments in the United States are registered with the FDA to make Growing Rod System (product code PGM). 14 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Growing Rod System
- Product code
- PGM
- Country
- United States
Makers of Growing Rod System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 2 | September 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 2 | February 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 2 | February 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | December 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 1 | November 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 1 | March 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Manufacturer, Specification developer | 1 | July 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 1 | February 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 1 | November 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | November 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 1 | February 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH - Quakertown | Quakertown, PA, 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 | |
| B & J Medical LLC | Kendallville, IN, United States | 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 | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Single Source Medical LLC | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vorzeigen | Connersville, IN, 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.