SYNTHES (USA) SPHERICAL WASHERS— 510(k) K052483
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K052483 for SYNTHES (USA) SPHERICAL WASHERS, Substantially Equivalent on 2005-11-04. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code NDG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- 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.