SELECT SHOULDER PEGGED ALL-POLY GLENOID— 510(k) K962244

Name: FDA 510(k) clearance K962244
Creator: U.S. Food and Drug Administration
Published: 1996-08-09

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K962244 for SELECT SHOULDER PEGGED ALL-POLY GLENOID, Substantially Equivalent for Some Indications on 1996-08-09. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 1996-06-11
Decision date: 1996-08-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.