Chrysalis Intelligence · Sponsors · Depuy Mitek

Depuy Mitek

Raynham, MA, US · 5 510(k) clearances

Total clearances
5
2024-02-26 → 2026-02-26
Last 12 months
1
Product codes
3
Most recent
2026-02-26
Name variants in FDA filings: Depuy Mitek / DePuy Mitek, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAI Fastener, Fixation, Biodegradable, Soft Tissue Class II Orthopedic 3 2025-02-05
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2026-02-26
HRX Arthroscope Class II Orthopedic 1 2024-02-26
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-02-26 K253791 PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid KCT Class II General Hospital
2025-02-05 K243790 GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor MAI Class II Orthopedic
2024-09-11 K241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors MAI Class II Orthopedic
2024-03-15 K240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw MAI Class II Orthopedic
2024-02-26 K233675 FMS VUE™ Fluid Management and Tissue Debridement System HRX Class II Orthopedic