DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0— 510(k) K080918
Substantially EquivalentDepuy Mitek
FDA 510(k) clearance K080918 for DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0, Substantially Equivalent on 2008-04-23. Applicant: Depuy Mitek. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek
- 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
- Special
- Location
- Raynham, MA, US
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More clearances from Depuy Mitek
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.