Theken Spine LLC

3 devices in the database

  • Model / Serial
    Model Number: 50-05-0010; Lot Number: A07D02B.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- TX.
  • Product Description
    iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
  • Model / Serial
    Part Number is 50-20-001. Lot #: 100549 Overall kit Exp. Date: 02/2010, Syringe Exp. Date 10/2009, Marrow Loc Exp. Date: 02/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 02/2010; Lot #103016 Overall kit Exp. Date: 10/2010, Syringe Exp Date: 10/2009, Marrow Loc Exp. Date: 10/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 10/2010.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
  • Product Description
    Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
  • Model / Serial
    Lot # A08F01E Exp Date 2010-06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of FL, OH, TX, and UT.
  • Product Description
    FormPutty Bone Void Filler 10cc || The product is sealed in a foil pouch and then placed in a box following sterilization. || Part # 50-07-0100 || Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.

2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Theken Spine Llc, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    Theken Spine LLC, 283 E Waterloo Rd, Akron OH 44319-1238
  • Source
    USFDA