K201676 is an FDA 510(k) clearance for the Barricaid Instrument Tray. This device is classified as a Defect Measurement Tool (Class II - Special Controls, product code QHG).
Submitted by Intrinsic Therapeutics, Inc. (Woburn, US). The FDA issued a Cleared decision on July 16, 2020, 27 days after receiving the submission on June 19, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4510. 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) Number | K201676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2020 |
| Decision Date | July 16, 2020 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QHG - Defect Measurement Tool |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4510 |
| 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. |