Data / Medical devices / Burr, Orthopedic / United States
FDA-registered makers of Burr, Orthopedic in the United States: 33 establishments
33 establishments in the United States are registered with the FDA to make Burr, Orthopedic (product code HTT). 0 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
- Burr, Orthopedic
- Product code
- HTT
- Country
- United States
Makers of Burr, Orthopedic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aegis Meditec, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLW, Inc. | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gsource, LLC. | Emerson, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holmed LLC | Attleboro, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumental Machine & Development, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Orthopedics Inc. | Arlington, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopedic Sciences, Inc | Overland Park, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southern Carbide Specialists, Inc. | Quitman, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suretek Medical | Greenville, SC, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, 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.