COPELAND MB/HA RESURFACING HUMERAL HEADS— 510(k) K010827
Substantially EquivalentBiomet Orthopedics, Inc.
FDA 510(k) clearance K010827 for COPELAND MB/HA RESURFACING HUMERAL HEADS, Substantially Equivalent on 2001-09-14. Applicant: Biomet Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Orthopedics, Inc.
- Product code
- Code HSD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3690
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HSD
view allMore clearances from Biomet Orthopedics, Inc.
view allAdverse events under product code HSD
product code HSD- Injury
- 3,425
- Malfunction
- 531
- Total
- 3,956
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 K010827
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010827.
Data sourced from openFDA. This site is unofficial and independent of the FDA.