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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BodyFX
INMODE M.D LTD
AS600874A
In Commercial Distribution

  • 07290016633085 ()
AS600874A

  • Radio-frequency skin surface treatment system
Forma
INMODE M.D LTD
AG603799A
In Commercial Distribution

  • 07290016633061 ()
AG603799A

  • Radio-frequency skin surface treatment system
Fractora 24P
INMODE M.D LTD
AG602426A
In Commercial Distribution

  • 17290016633150 ()
  • 07290016633153 ()
AG602426A

  • Radio-frequency skin surface treatment system
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
1601-0001
In Commercial Distribution

  • 00815432023264 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0001

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023097 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0000

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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