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510(k) Data Aggregation
K Number
K222799Device Name
Haymaker® Screw System
Manufacturer
Date Cleared
2023-01-10
(116 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
OrthoCircle Spine d
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Device Description
The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.
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K Number
K193472Device Name
OrthoCircle Spine Pedicle Screw System
Manufacturer
Date Cleared
2020-02-13
(59 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
OrthoCircle Spine
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).
Device Description
The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device to be implanted from the posterior approach. The system consists of rods, poly-axial screws and set screws. The screws are available in diameters from Ø4.50mm to Ø7.50mm and in lengths of 20mm to 60mm. Standard and Reduction Pedicle Screws are available in these sizes. Titanium rods are available in Ø5.50mm diameter straight and pre-contoured. Set screws are used to fasten the rods and poly-axial screws. Implants are provided sterile in individual packaging.
Special instruments are used to implant the pedicle system. Instruments used to implant the pedicle screw system are provided as non-sterilization prior to use.
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