MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
FDA 510(k) K240441 · Depuy Mitek
510(k) numberK240441
Submission
- Device name
- MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
- Applicant
- Depuy Mitek
Raynham, MA, US - Received
- February 14, 2024
- Decision date
- March 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAI · Special | 09/11/2024SE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement SystemHRX · Traditional | 02/26/2024SE |
| K143475 | VAPR Tripolar Suction ElectrodeGEI · Traditional | 04/03/2015SE |
| K120449 | Healix Advance PEEK AnchorHWC · Traditional | 05/11/2012SE |
| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…NEW · Special | 04/23/2008SE |
| K060664 | Fastin RC AnchorHWC · Traditional | 06/06/2006SE |
| K043298 | Blue Orthocord SutureNEW · Special | 12/10/2004SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | 05/28/2004SE |
Questions and answers
When was MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw cleared by the FDA?
MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (K240441) received a 510(k) decision of Substantially Equivalent on March 15, 2024, 30 days after the submission was received.
What is the product code of K240441?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.