Data / Medical devices / United States / 3D Medical Applications Center (3D Mac)
3D Medical Applications Center (3D Mac): FDA-registered device maker in Bethesda, MD, United States, 1 510(k) clearance
3D Medical Applications Center (3D Mac) is registered with the FDA (registration 3048181693) in Bethesda, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3048181693
- Address
- 8901 Wisconsin Ave. President Zone, Bldg. 1, Level 4, Room 4417B, Bethesda, MD, United States, 20889
- Owner or operator
- 3-D Medical Applications Center (3-D MAC) (10096181)
- Roles
- Manufacturer
- First device listed
- July 17, 2026
- Registered through
- 2026
- Brand names listed
- 3D MAC Titanium Cranial Plate System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Cranioplasty, Preformed, Alterable | GWO | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K253116 | 3D MAC Titanium Cranial Plate (TCP) System | GXN | Substantially Equivalent | The Surgeon General, Department of the Army (TSG-DA) | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Cranioplasty, Preformed, Non-Alterable
- All makers of Plate, Cranioplasty, Preformed, Alterable
Updated June 18, 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.