Stryker Biotech

  • Model / Serial
    OP-1 Putty, Catalog #300-50 Lot Number Expiry Date FC0902004 8/31/2009 FC0902005 8/31/2009 FC0903002 8/31/2009 FC0903004 8 /31/2009 FC0903005 8/31/2009 FC0905003 3/31/2010 FC0905005 3/31/2010 FC0906002 4/30/2010 FC0907002 4/30/2010 FC0907005 4/30/2010 FC0908001 4/30/2010 FC0908003 2/28/2010 FC0908004 4/30/2010 FC0908006 4/30/2010 FC0909005 4/30/2010  OP-1 Putty, catalog #300-55 Lot Number Expiry Date FC0909002 8/31/2010 FC0909003 8/31/2010 FC0909004 8/31/2010 FC0909008 8/31/2010 FC0909009 8/31/2010 FC0909012 8/31/2010 FC0909013 8/31/2010 FC0910003 8/31/2010 FC0910004 8/31/2010 FC0911001 8/31/2010 FC0911002 8/31/2010 FC0912002 8/31/2010 FC0912004 8/31/2010 FC1001002 8/31/2010 FC1002001 8/31/2010 FC1002004 8/31/2010 FC1002005 8/31/2010 FC1003001 10/31/2010 FC1003003 10/31/2010 FC1004001 10/31/2010 FC1005001 10/31/2010 FC1005002 10/31/2010 FC1005003 10/31/2010 FC1006001 10/31/2010 FC1007001 1/31/2012 FC1007004 1/31/2012 FC1007005 1/31/2012 FC1007006 1/31/2012 FC1007007 1/31/2012 FC1008001 1/31/2012 FC1008002 1/31/2012 FC1009002 1/31/2012 FC1009004 1/31/2012 FC1009005 1/31/2012
  • Product Classification
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) || "Catalog numbers: 300-50, 300-55 || OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Biotech, 35 South St, Hopkinton MA 01748-2218
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. || Catalog Number: 100-25
  • Manufacturer