BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Craniomaxillofacial Distraction System (CMFD)

    K Number: K170818 · Decision Dec 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    16
    Review Days
    262

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Craniomaxillofacial Distraction System (CMFD)
    K Number
    K170818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    March 20, 2017
    Decision Date
    December 7, 2017
    Product Code
    PBJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBJ Cranial Distraction System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PBJ), ordered by most recent decision date.

    CranioXpand

    FDA 510(k)
    FDA Class 2 ·Neurology

    Internal Distraction - Sterile

    FDA 510(k)
    FDA Class 2 ·Neurology

    RxG Distraction System

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSTEOMED CRANIAL DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Synthes USA Products, LLC

    K Number Device Name
    K180541 DePuy Synthes 2.0 mm Quick Insertion Screws
    K162594 Craniomaxillofacial Distraction System (CMFD)
    K170654 USS System
    K161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
    K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
    K151276 DePuy Synthes T-PAL Ti Spacer
    K143285 Mandible External Fixator - MR Conditional
    K142838 Synapse Occipital-Cervical-Thoracic (OCT) System
    K141897 SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
    K133698 SYNAPSE SYSTEM
    Search all 16 clearances from Synthes USA Products, LLC →