DePuy Synthes Static Staples— 510(k) K180544
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K180544 for DePuy Synthes Static Staples, Substantially Equivalent on 2018-07-24. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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Adverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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.