ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM— 510(k) K050761
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K050761 for ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM, Substantially Equivalent on 2005-04-11. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code KWT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3650
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
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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, through . 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.