Manufacturers

SpineFrontier, Inc.

32 devices in the database

Device Recall SpineFrontier PedFuse Pedicle Screw System
  • Model / Serial
    Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TX, OH, VA, and Washington, DC.
  • Product Description
    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Device Recall SpineFrontier
  • Model / Serial
    Revision E
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TX, KS, CO, and MA
  • Product Description
    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Case/Caddy (tray, surgical, instrument)
  • Model / Serial
    Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Numbers: 7197.024, 011649, 011498; Invue Lid: SI70095A, Lot Number: 6250.009-R; S-Lift Lid: SI50070A, Lot Number: 7201.008; S-Lift Base: SI50067A; Lot Numbers: 7183.007R, 7201.007; Arena-C Lid: 11-72013D, 11-72014D, Lot Numbers: 011969-001, 011969-002; Generics Lid: 12-99005A, Lot Number: 8372.001.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.
  • Product Description
    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. || System cases are designed to hold and secure all instrumentation to be used with a surgical system.
SLIFT Slap Hammer
  • Model / Serial
    Lot: 56H26
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distributions to states of: KS and TX.
  • Product Description
    S-LIFT Slap Hammer, Part Number: 11-50204, Revision A || The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
ArenaL Trials (Handles and Heads)
  • Model / Serial
    CT128047, CT128048
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: VA only.
  • Product Description
    Arena-L Trial Handle; Part: 11-81002 || The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
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