MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM— 510(k) K081747
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K081747 for MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM, Substantially Equivalent on 2008-09-05. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code NEI
- Device class
- Class 2
- Regulation
- 21 CFR 872.4770
- Advisory panel
- Dental
- 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.