HEALIX ADVANCE PEEK ANCHOR— 510(k) K120449
Substantially EquivalentDepuy Mitek
FDA 510(k) clearance K120449 for HEALIX ADVANCE PEEK ANCHOR, Substantially Equivalent on 2012-05-11. Applicant: Depuy Mitek. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Recent devices under product code HWC
view allMore clearances from Depuy Mitek
view all- K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
- K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
- K143475 — VAPR Tripolar Suction Electrode
- 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 HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.