GLOBAL AP POROUS COATED HUMERAL STEM— 510(k) K063652
Substantially EquivalentDePuy Orthopaedics, Inc.
FDA 510(k) clearance K063652 for GLOBAL AP POROUS COATED HUMERAL STEM, Substantially Equivalent on 2007-02-01. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- DePuy Orthopaedics, Inc.
- Product code
- Code MBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3670
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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More clearances from DePuy Orthopaedics, Inc.
view allAdverse events under product code MBF
product code MBF- Injury
- 597
- Total
- 597
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.