SOLAR 2 ANATOMIC SHOULDER— 510(k) K040432

Name: FDA 510(k) clearance K040432
Creator: U.S. Food and Drug Administration
Published: 2005-01-07

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K040432 for SOLAR 2 ANATOMIC SHOULDER, Substantially Equivalent on 2005-01-07. Applicant: Stryker Orthopaedics. Device class: 2.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2004-02-19
Decision date: 2005-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSD

view all

K233260 — Univers Revers CA Head and Adapter2024-02-12
K221232 — Univers Revers Humeral Cup Implant2022-05-19
K191433 — AGILON® XO Shoulder Replacement System2020-11-12
K193122 — Biocore9 Humeral Resurfacing System2020-05-15
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

More clearances from Stryker Orthopaedics

view all

K211703 — Insignia Hip Stem2021-08-16
K191414 — EXETER Centralizer, EXETER 2.5mm Plug2019-08-28
K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
K173849 — Triathlon Total Knee System2018-02-02
K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System2017-10-30

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.