RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL— 510(k) K140324
Substantially EquivalentDepuy Mitek, A Johnson and Johnson Company
FDA 510(k) clearance K140324 for RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL, Substantially Equivalent on 2014-07-07. Applicant: Depuy Mitek, A Johnson and Johnson Company. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek, A Johnson and Johnson Company
- Product code
- Code MBI
- 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 MBI
view allMore clearances from Depuy Mitek, A Johnson and Johnson Company
view all- K150209 — Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus +2 more
- K140643 — GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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.