Devices

Device Recall Kelyniam CSI

  • Model / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
  • Manufacturer
    Kelyniam Global, Inc.
  • 1 Event

Manufacturer

Kelyniam Global, Inc.
  • Manufacturer Address
    Kelyniam Global, Inc., 97 River Rd, Collinsville CT 06019-3246
  • Manufacturer Parent Company (2017)
    Kelyniam Global, Inc.
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall Kelyniam CSI
  • Model / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI111715-KH1 CSI072814-JB1 CSI082514-MA1 CSI080714-CT1 CSI091914-JW1 CSI101614-TR1 CSI041415-MZ1 CSI100915-DD1 CSI120215-MM1 CSI100915-DD2 CSI011816-TA1 CSI012016-RT1A CSI012716-MP1 CSI021116-CA1 CSI030716-BC1 CSI040716-CK1 CSI060916-DF1 CSI070716-AC1 CSI092116-JA1 CSI110416-DW1 CSI120616-LS1 CSI012417-SD1 CSI062617-HR1
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
  • Manufacturer
    Kelyniam Global, Inc.
Device Recall Kelyniam CSI
  • Model / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI041216-CM1 CSI092016-LD1L
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
  • Manufacturer
    Kelyniam Global, Inc.
Device Recall Kelyniam CSI
  • Model / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI070314-JF1 CSI082214-EC1 CSI090314-CG1 CSI091614-JB1 CSI101414-RA1 CSI110514-SS2 CSI120814-JC1 CSI121114-DD1 CSI121614-LG1 CSI121714-OL1 CSI011615-AC1 CSI012915-JG1 CSI012915-SS1 CSI022415-HL1 CSI040615-RA1 CSI060115-EB1 CSI102215-CT1 CSI112415-ES1 CSI101615-BE1 CSI012016-RT1B CSI022916-CS1 CSI032216-SP1 CSI020216-JR1 CSI051716-TM1 CSI070516-AT1 CSI070116-EG1 CSI072816-JE1 CSI092716-AV1 CSI101416-TY1 CSI110816-CS1 CSI112316-NK1 CSI092616-CB1 CSI111516-RB1 CSI113016-NR1 CSI111616-FH1 CSI010517-JH1 CSI041417-KK1 CSI060117-AR1 CSI062617-LV1 CSI071017-NS1A CSI081717-GG1 CSI081717-JM1 CSI082717-LH1 CSI082917-UK1 CSI081717-JM1 CSI090617-JH2 CSI092717-DH1 CSI092617-OT1 CSI100417-EZ1 CSI100517-AE1 CSI100617-MH1 CSI101817-KD1 CSI102617-NK1 CSI101617-JF1B
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
  • Manufacturer
    Kelyniam Global, Inc.