NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY— 510(k) K102018
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K102018 for NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY, Substantially Equivalent on 2010-09-23. Applicant: Synthes USA Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes USA Products, LLC
- 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.