SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS— 510(k) K962224

Name: FDA 510(k) clearance K962224
Creator: U.S. Food and Drug Administration
Published: 1996-08-28

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K962224 for SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS, Substantially Equivalent on 1996-08-28. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 1996-06-10
Decision date: 1996-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWS

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K260721 — Tornier Perform Advanced Glenoid2026-07-22
K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
K252418 — Catalyst F1x Shoulder System2025-11-06
K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

More clearances from Intermedics Orthopedics

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K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.