HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors— 510(k) K241010
Substantially EquivalentDepuy Mitek
FDA 510(k) clearance K241010 for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors, Substantially Equivalent on 2024-09-11. Applicant: Depuy Mitek. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Raynham, MA, US
Recent devices under product code MAI
view allMore clearances from Depuy Mitek
view all- K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
- K143475 — VAPR Tripolar Suction Electrode
- K120449 — HEALIX ADVANCE PEEK ANCHOR
- K080918 — DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.