Data / Medical devices / United States / Insight Surgery Houston
Insight Surgery Houston: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances
Insight Surgery Houston is registered with the FDA (registration 3027329005) in Houston, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027329005
- Address
- TMC Innovation 2450 Holcombe Blvd, Suite 1820, Houston, TX, United States, 77021
- Owner or operator
- 3D LifePrints UK (10085716)
- Roles
- Manufacturer
- First device listed
- February 8, 2023
- Registered through
- 2026
- Brand names listed
- EmbedMed
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Driver, Wire, And Bone Drill, Manual | DZJ | 2 | Manufacturer | accessdata.fda.gov |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| February 1, 2023 | K221943 | EmbedMed | PBF | Substantially Equivalent | 3D Lifeprints UK , Ltd. | accessdata.fda.gov |
| September 30, 2022 | K220366 | EmbedMed | DZJ | Substantially Equivalent | 3D Lifeprints UK , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopaedic Surgical Planning And Instrument Guides
- All makers of System, Image Processing, Radiological
- All makers of Driver, Wire, And Bone Drill, Manual
Updated February 1, 2023. 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.