BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS— 510(k) K131135
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K131135 for BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS, Substantially Equivalent on 2014-01-22. Applicant: Biomet Manufacturing Corp.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code MBB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Adverse events under product code MBB
product code MBB- Death
- 27
- Injury
- 1,412
- Malfunction
- 551
- Total
- 1,990
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.