Defect Measurement Tool
The Defect Measurement Tool is a manual surgical instrument used in orthopedic surgery to measure anatomical features in order to determine appropriate patient selection for an orthopedic implant. The geometry and specifications of the instrument are defined by the requirements of the corresponding orthopedic implant in terms of surgical technique and device use. It is classified as FDA Class 2, requiring 510(k) clearance, under the Orthopedic medical specialty. The product code is QHG, regulated under 21 CFR 888.4510, and it is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- QHG
- Device Class
- FDA class 2
- Regulation Number
- 888.4510
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201676 | Barricaid Instrument Tray | Jul 16, 2020 | Substantially Equivalent | Intrinsic Therapeutics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.