510(k) K201676
K201676 is an FDA 510(k) premarket notification submitted by Intrinsic Therapeutics, Inc. for the device "Barricaid Instrument Tray". The FDA issued a decision of Substantially Equivalent on July 16, 2020. The device falls under product code QHG (Defect Measurement Tool), a Class II device regulated under 21 CFR 888.4510.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2020
- Date Received
- June 19, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Defect Measurement Tool
- Device Class
- Class II
- Regulation Number
- 888.4510
- Review Panel
- OR
- Submission Type
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.