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)

510(k) number: K241008
Device name: 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)
Applicant: Relign Corporation, Subsidiary of Zimmer Biomet CA · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2024-05-08
Date received: 2024-04-12
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K241008.pdf

Official FDA record: K241008

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