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    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    FDA Enforcement
    Class II ·Terminated·Kiscomedica S.A.·March 22, 2017

    LABORATOIRE BONGERT

    Importer
    🇫🇷 France·1 Manufacturer

    Laboratoires Gilbert

    Manufacturer
    🇫🇷 France·9 Basic UDI-DIs·13 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

    Laboratoire Unither

    Manufacturer
    🇫🇷 France·139 Basic UDI-DIs·139 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

    LABORATOIRES EUROMEDIS

    Manufacturer
    🇫🇷 France·72 Basic UDI-DIs·113 Devices·GMED SAS, GMED SAS, GMED SAS, and GMED SAS

    SOFT MEDICAL AESTHETICS

    Manufacturer
    🇫🇷 France·51 Basic UDI-DIs·51 Devices·GMED SAS, GMED SAS, and GMED SAS

    Laboratoire de la Mer

    Manufacturer
    🇫🇷 France·6 Basic UDI-DIs·6 Devices·GMED SAS, GMED SAS, and GMED SAS

    Messer France

    Manufacturer
    🇫🇷 France·11 Basic UDI-DIs·16 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    ACTEON MANUFACTURING

    Manufacturer
    🇫🇷 France·12 Basic UDI-DIs·77 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

    MAYOLY PHARMA FRANCE

    Manufacturer
    🇫🇷 France·2 Basic UDI-DIs·2 Devices·ITALCERT SRL and ITALCERT SRL

    ADTMed

    Manufacturer
    🇫🇷 France·7 Basic UDI-DIs·8 Devices·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

    PARSYS TELEMEDECINE

    Manufacturer
    🇫🇷 France·3 Basic UDI-DIs·3 Devices·GMED SAS and GMED SAS

    HEMODIA SAS

    Manufacturer
    🇫🇷 France·54 Basic UDI-DIs·192 Devices·GMED SAS, GMED SAS, and GMED SAS

    La Brosse et Dupont

    Manufacturer
    🇫🇷 France·11 Basic UDI-DIs·34 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

    3S ORTHO

    Manufacturer
    🇫🇷 France·14 Basic UDI-DIs·14 Devices·Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., and Kiwa Belgelendirme Hizmetleri A.Ş.

    Graftys

    Manufacturer
    🇫🇷 France·4 Basic UDI-DIs·4 Devices·National Standards Authority of Ireland (NSAI) and National Standards Authority of Ireland (NSAI)

    Linde France

    Manufacturer
    🇫🇷 France·8 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    ALN

    Manufacturer
    🇫🇷 France·19 Basic UDI-DIs·19 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    EUROSILICONE SAS

    Manufacturer
    🇫🇷 France·490 Basic UDI-DIs·490 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    Rocamed France

    Manufacturer
    🇫🇷 France·25 Basic UDI-DIs·25 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS