JUGGERKNOT MINI SOFT ANCHOR— 510(k) K140908
Substantially EquivalentBiomet Sports Medicine
FDA 510(k) clearance K140908 for JUGGERKNOT MINI SOFT ANCHOR, Substantially Equivalent on 2014-10-02. Applicant: Biomet Sports Medicine. Device class: 2.
Clearance details
- Applicant
- Biomet Sports Medicine
- Product code
- Code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code DZL
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- K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
- K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
Adverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
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.