BIOMET LATERAL TROCH PLATE— 510(k) K003294
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K003294 for BIOMET LATERAL TROCH PLATE, Substantially Equivalent on 2000-11-03. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code JDW
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code JDW
view allMore clearances from Biomet, Inc.
view allAdverse events under product code JDW
product code JDW- Injury
- 717
- Total
- 717
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 →
Recalls naming K003294
K-number listed on FDA's recall record- Z-0296-2018 — Lateral Troch Plate Full Crimp - 254mm, model # 350837
- Z-0297-2018 — Lateral Troch Plate Full Crimp - 254mm, model # 350838
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003294.
Data sourced from openFDA. This site is unofficial and independent of the FDA.