LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS— 510(k) K101730
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K101730 for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS, Substantially Equivalent on 2010-12-03. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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Adverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
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.