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U.S. Department of Health and Human Services

Product Classification

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Device defect measurement tool
Definition Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
Physical State This is a stainless steel, non powered single component instrument (tool).
Technical Method This is a manual surgical instrument with sizes to measure an anatomic feature(s).
Target Area This is used to measure an anatomic feature on the body as dictated by the associated orthopedic implant.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQHG
Premarket Review Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.4510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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