MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079— 510(k) K101835
Substantially EquivalentPorex Surgical, Inc.
FDA 510(k) clearance K101835 for MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079, Substantially Equivalent on 2010-12-03. Applicant: Porex Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Porex Surgical, Inc.
- Product code
- Code HBW
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newnan, GA, US
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More clearances from Porex Surgical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.