Distal Centralizers— 510(k) K193546
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K193546 for Distal Centralizers, Substantially Equivalent on 2020-09-25. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code JDG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDG
view all- K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
- K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
- K992234 — THE TAPER-FIT TOTAL HIP SYSTEM
- K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
More clearances from Biomet, Inc.
view allAdverse events under product code JDG
product code JDG- Injury
- 804
- Malfunction
- 3,242
- Total
- 4,046
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.