Memodyn Staple— 510(k) K161587
Substantially EquivalentAustin & Associates, Inc./Telos Medical Equipment
FDA 510(k) clearance K161587 for Memodyn Staple, Substantially Equivalent on 2017-02-01. Applicant: Austin & Associates, Inc./Telos Medical Equipment.
Clearance details
- Applicant
- Austin & Associates, Inc./Telos Medical Equipment
- Product code
- Code JDR
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Millersville, MD, US
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.