K162419 is an FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide. This device is classified as a Pedicle Screw Placement Guide (Class II - Special Controls, product code PQC).
Submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on October 28, 2016, 59 days after receiving the submission on August 30, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. A Pedicle Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Pedicle Screws That Are Used To Anchor Pedicle Screw Spinal Systems Onto The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans..
| 510(k) Number | K162419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2016 |
| Decision Date | October 28, 2016 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PQC - Pedicle Screw Placement Guide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | A Pedicle Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Pedicle Screws That Are Used To Anchor Pedicle Screw Spinal Systems Onto The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans. |