RESORBABLE SOFT TISSUE ATTACHMENT DEVICE— 510(k) K950275

Substantially Equivalent for Some Indications

Zimmer, Inc.

FDA 510(k) clearance K950275 for RESORBABLE SOFT TISSUE ATTACHMENT DEVICE, Substantially Equivalent for Some Indications on 1995-11-07. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1995-01-23
Decision date: 1995-11-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.