Data / Medical devices / United States / Celestray Biotech Company, LLC.
Celestray Biotech Company, LLC.: FDA-registered device maker in Bethesda, MD, United States, 2 510(k) clearances
Celestray Biotech Company, LLC. is registered with the FDA (registration 3027699572) in Bethesda, MD, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027699572
- Address
- 8712 Irvington Ave, Bethesda, MD, United States, 20827
- Owner or operator
- CelestRay Biotech Company, LLC. (10088488)
- Roles
- Specification developer
- First device listed
- July 31, 2023
- Registered through
- 2026
- Brand names listed
- Rebuilder, Rebuilder Nerve Guidance Condiut, SpinMedix, SpinMedix Absorbable Fibrous Membrane
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | 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 29, 2024 | K230794 | Rebuilder Nerve Guidance Conduit | JXI | Substantially Equivalent | Celestray Biotech Company, LLC., | accessdata.fda.gov |
| July 6, 2023 | K222220 | SpinMedix Absorbable Fibrous Membrane | OWW | Substantially Equivalent | Celestray Biotech Company, LLC., | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical, Polymeric
- All makers of Cuff, Nerve
Updated January 29, 2024. 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.