UNIGLIDE UNICONDYLAR KNEE PROSTHESIS— 510(k) K050764

Name: FDA 510(k) clearance K050764
Creator: U.S. Food and Drug Administration
Published: 2005-08-24

Substantially Equivalent

Corin USA

FDA 510(k) clearance K050764 for UNIGLIDE UNICONDYLAR KNEE PROSTHESIS, Substantially Equivalent on 2005-08-24. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant: Corin USA
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 2005-03-24
Decision date: 2005-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

view all

K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K190633 — NanoOrtho NanoKnee® System2019-12-20
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

More clearances from Corin USA

view all

K203751 — OMNIVision system2021-04-12
K202805 — Optimized Positioning System (OPS) Insight2020-11-20
K193545 — Corin Optimized Positioning System (OPS) Femoral2020-08-04
K193042 — Optimized Positioning System (OPS) ReView2020-06-26
K192656 — Optimized Positioning System (OPS) Insight2020-05-01

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.