CONCORD Plus Radiopaque Bone Cement— 510(k) K162618
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K162618 for CONCORD Plus Radiopaque Bone Cement, Substantially Equivalent on 2017-01-23. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Code NDN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
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Adverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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.