Taps for Resorbable Screws— 510(k) K153587
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K153587 for Taps for Resorbable Screws, Substantially Equivalent on 2017-01-18. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code HBG
- Device class
- Class 2
- Regulation
- 21 CFR 882.4300
- 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.