Data / Medical devices / United States / Relign Corporation
Relign Corporation: FDA-registered device maker in Santa Clara, CA, United States, 3 510(k) clearances
Relign Corporation is registered with the FDA (registration 3012790575) in Santa Clara, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 8, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012790575
- Address
- 1725 De La Cruz Blvd Ste 7, Santa Clara, CA, United States, 95050
- Owner or operator
- RELIGN Corporation (10053774)
- Roles
- Specification developer
- First device listed
- January 10, 2017
- Registered through
- 2027
- Brand names listed
- Relign Arthroscopic System, Tricera, Tricera Arthroscopic System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| May 8, 2024 | K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | GEI | Substantially Equivalent | Relign Corporation, Subsidiary of Zimmer Biomet | accessdata.fda.gov |
| November 28, 2023 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) | GEI | Substantially Equivalent | Relign Corporation | accessdata.fda.gov |
| January 4, 2017 | K162770 | Relign System | GEI | Substantially Equivalent | Relign Corporation | accessdata.fda.gov |
Compare with other makers
Updated May 8, 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.