NORIAN CRS BONE CEMENT— 510(k) K060445
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K060445 for NORIAN CRS BONE CEMENT, Substantially Equivalent on 2006-04-13. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code GXP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.