Product Classification

• 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 Code: QHG
• Premarket Review: Office of 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