Data / Medical devices / United States / Graham Medical Technologies, L.L.C. d.b.a. GraMedica
Graham Medical Technologies, L.L.C. d.b.a. GraMedica: FDA-registered device maker in Rochester, MI, United States, 5 510(k) clearances
Graham Medical Technologies, L.L.C. d.b.a. GraMedica is registered with the FDA (registration 3004993707) in Rochester, MI, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 10, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004993707
- Address
- 236 Mill St, Rochester, MI, United States, 48307
- Owner or operator
- GRAMEDICA (9069880)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 2, 2007
- Registered through
- 2026
- Brand names listed
- Graham Decompression Scissors, Guide Wire, HYP Sinus Tarsi Decompression Scissors, HyProCure Driver, HyProCure II Driver, HyProCure II Positioning Sleeve, HyProCure II Trial Sizer 06, HyProCure II Trial Sizer 07 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Complaint file establishment | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2017 | K162179 | osteo-WEDGE II ® Open Wedge Bone Locking Plate System | HRS | Substantially Equivalent | Graham Medical Technologies, LLC Dba Gramedica | accessdata.fda.gov |
| May 29, 2015 | K142478 | opti-Toe | HTY | Substantially Equivalent | Graham Medical Technologies, LLC (D.B.A.Gramedica) | accessdata.fda.gov |
| October 3, 2014 | K142534 | HyProCure II | HWC | Substantially Equivalent | Graham Medical Technologies, LLC Dba Gramedica | accessdata.fda.gov |
| July 6, 2011 | K111326 | OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM | HRS | Substantially Equivalent | Graham Medical Technologies, LLC | accessdata.fda.gov |
| September 16, 2004 | K042030 | HYPROCURE SUBTALAR IMPLANT SYSTEM | HWC | Substantially Equivalent | Graham Medical Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Pin, Fixation, Smooth
- All makers of Scissors, Orthopedic, Surgical
Updated January 10, 2017. 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.