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

    BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS

    K Number: K001046 · Decision Jun 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    41
    Review Days
    69

    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
    BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
    K Number
    K001046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biopro, Inc.
    Date Received
    March 31, 2000
    Decision Date
    June 8, 2000
    Product Code
    KWS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

    Similar 510(k) Clearances

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

    AETOS Shoulder System - CONCELOC Glenoids

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Catalyst F1x Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AETOS Shoulder System Meta Humeral Prosthesis Size 0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MyShoulder Planner (5.3SSWPL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System (Tornier HRS)

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

    Other Clearances by Biopro, Inc.

    K Number Device Name
    K163627 Shotel Ankle Arthrodesis Nail System
    K162674 BioPro Foot Plating Systems
    K132510 BIOPRO - INFINITY PLATE ANCHOR SYSTEM
    K130298 BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
    K121973 BIOPRO HEMI-EDGE TOE SYSTEM
    K100761 BIOPRO POLAR HEAD
    K101030 MODIFICATION TO HBS HEADLESS BONE SCREW
    K090208 BIOPRO FEMORAL HEADS
    K083490 BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
    K082705 BIOPRO BIPOLAR HEAD, MODELS 18130-18152
    Search all 41 clearances from Biopro, Inc. →