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)

510(k) number: K233493
Device name: 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)
Applicant: Relign Corporation CA · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2023-11-28
Date received: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K233493.pdf

Official FDA record: K233493

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.