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This document provides a summary of safety and effectiveness for the TWINFIX Ultra Ti, PK, and HA suture anchors, detailing the intended use, indications, device characteristics, and regulatory information
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How to fill out 510k summary of safety
How to fill out 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors
01
Begin by gathering all relevant data about TWINFIX Ultra Ti, PK, HA suture anchors.
02
Include a cover page with the device name and applicant information.
03
Provide a summary of the device description including materials and intended use.
04
Outline the intended indications for use clearly.
05
Compare TWINFIX Ultra Ti suture anchors with predicate devices, noting similarities and differences.
06
Detail the performance data, including any lab testing results, clinical data, and risk assessments.
07
Present the manufacturing process and quality control measures taken.
08
Summarize the labeling information, including instructions for use and any warnings.
09
Ensure compliance with FDA guidelines and include any additional requested information.
10
Review all sections thoroughly and consult with regulatory experts if necessary before submission.
Who needs 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
01
Manufacturers or developers of TWINFIX Ultra Ti, PK, HA suture anchors seeking to market their product in the U.S.
02
Regulatory affairs professionals involved in compliance and submission processes.
03
Healthcare providers and hospitals planning to use or stock the suture anchors for surgical applications.
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People Also Ask about
What are the side effects of suture anchors?
Biodegradable anchors can break on insertion, as well as lead to osteolysis, loosening, failure of labral healing, and cause concerns about liberation products of degradation on cartilage.
How long do suture anchors last?
Despite the general impression by most surgeons that bioabsorbable anchors dissolve by 6 months, implant degradation has not been demonstrated to occur reliably within 2 years.
Can suture anchors break?
There are times when anchors may not last forever. Busy shoulder surgeons have all seen anchors that have “backed out” of bone. Anchors may “come out” of bone for one of 2 main reasons: The anchor broke or malfunctioned.
What is the failure rate of suture anchors?
The failure rate ranged from 1.2% to 5.6%. Prior studies could not find a statistical difference between different techniques but do show a trend toward a lower failure rate of the EB technique compared with suture anchors in complete ruptures.
Are suture anchors safe?
As the usage of suture anchors has increased, various material-specific advantages and challenges have been reported. As a result, suture anchors are continually changing to become safer and more efficient.
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What is 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
The 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors is a document submitted to the FDA that provides evidence demonstrating that the device is safe and effective for its intended use, based on the comparison to a legally marketed predicate device.
Who is required to file 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
The manufacturer or importer of TWINFIX Ultra Ti, PK, HA suture anchors is required to file the 510(k) Summary of Safety and Effectiveness Information with the FDA before marketing the device in the United States.
How to fill out 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
To fill out the 510(k) Summary, the manufacturer must follow the FDA guidelines, which typically include providing device description, intended use, technological characteristics, performance data, labeling, and any additional information that supports the safety and effectiveness of the suture anchors.
What is the purpose of 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
The purpose of the 510(k) Summary is to provide the FDA and other stakeholders with information regarding the device's safety and effectiveness, ensuring that it meets regulatory requirements and is substantially equivalent to a predicate device already on the market.
What information must be reported on 510(k) Summary of Safety and Effectiveness Information for TWINFIX Ultra Ti, PK, HA suture anchors?
The information reported must include the device's name, intended use, description, the predicate device comparison, labeling, summary of safety and effectiveness data, and any clinical or non-clinical studies relevant to the evaluation of the device.
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