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The Syntorr K-wire and Pin System is indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

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This document is a 510(k) premarket notification from the FDA for a medical device called the "Syntorr K-wire And Pin System." It is a regulatory clearance letter, not a study report or technical specification outlining acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert adjudication, MRMC study, standalone performance, ground truth, training set size), and how ground truth was established is not available in the provided text.

The document primarily focuses on:

• Device Name: Syntorr K-wire and Pin System
• Regulation Number & Name: 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
• Regulatory Class: Class II
• Product Code: HTY, JDW
• Indications for Use: Open and percutaneous fixation of bone fractures, bone reconstructions, guide pins for insertion of other implantation through the skin, and traction pins.
• Regulatory Clearance: Substantial equivalence determination to predicate devices.

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