K220132 is an FDA 510(k) clearance for the FIREFLY® Cervical Navigation Guide. This device is classified as a Posterior Cervical Screw Placement Guide (Class II - Special Controls, product code QSD).
Submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on October 26, 2022, 281 days after receiving the submission on January 18, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3075. A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans..
| 510(k) Number | K220132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | October 26, 2022 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QSD - Posterior Cervical Screw Placement Guide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3075 |
| Definition | A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans. |