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The SteriSpine" PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine" PS System is intended for posterior, non cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.. fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpine™PS system includes Pedicle Screw and Rod. Components of SteriSpine™PS systems are made of Titanium Ta6V Eli grade conforming to ASTM F136.

SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. The components added within this submission include:

• New references of Pedicle screws, .
• New references of Straight Rods,
• New references of Rods, compatible with a new Rod holder
• 3 Instruments :
  • o Open Screw Extender PSANC024,
  • Open Set Screw Guide PSANC022, o
  • o Rod Holder PSANC025.

The provided 510(k) summary describes a spinal implant system and does not contain information related to an AI/ML device or a study assessing algorithm performance, such as acceptance criteria for diagnostic metrics or reader studies. Therefore, I cannot extract the requested information using the input provided.

This document describes a medical device called SteriSpine™PS and its modifications, which falls under the category of a pedicle screw spinal system. The performance data section refers to mechanical testing of the physical device and a review of literature for clinical data, not the performance of an AI/ML algorithm.

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