Craniomaxillofacial Distraction System (CMFD)— 510(k) K170818
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K170818 for Craniomaxillofacial Distraction System (CMFD), Substantially Equivalent on 2017-12-07. Applicant: Synthes USA Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes USA Products, LLC
- Product code
- Code PBJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code PBJ
view allMore clearances from Synthes USA Products, LLC
view all- K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- K212943 — SyntheCel Dura Repair
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K210408 — DePuy Synthes Variable Angle Locking Patella Plating System
- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Data sourced from openFDA. This site is unofficial and independent of the FDA.