BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM— 510(k) K110039
Substantially EquivalentBiomet Sports Medicine
FDA 510(k) clearance K110039 for BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM, Substantially Equivalent on 2011-05-03. Applicant: Biomet Sports Medicine. Device class: 2.
Clearance details
- Applicant
- Biomet Sports Medicine
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDQ
view allMore clearances from Biomet Sports Medicine
view all- K140908 — JUGGERKNOT MINI SOFT ANCHOR
- K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
- K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
Adverse events under product code JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
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.