ARIZONA RADIO CAPITELLAR TOTAL ELBOW— 510(k) K812322
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K812322 for ARIZONA RADIO CAPITELLAR TOTAL ELBOW, Substantially Equivalent on 1982-01-04. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code JDB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3160
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code JDB
product code JDB- Injury
- 352
- Total
- 352
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.