ORTHOCORD— 510(k) K123668
Substantially EquivalentDepuy Mitek, Inc., A Johnson and Johnson Company
FDA 510(k) clearance K123668 for ORTHOCORD, Substantially Equivalent on 2013-02-26. Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek, Inc., A Johnson and Johnson Company
- Product code
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
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More clearances from Depuy Mitek, Inc., A Johnson and Johnson Company
view allAdverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
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.