NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS— 510(k) K895226

Substantially Equivalent

3M Company

FDA 510(k) clearance K895226 for NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS, Substantially Equivalent on 1989-11-03. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 1989-08-14
Decision date: 1989-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, US

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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.