510(k) K220132
K220132 is an FDA 510(k) premarket notification submitted by Mighty Oak Medical, Inc. for the device "FIREFLY® Cervical Navigation Guide". The FDA issued a decision of Substantially Equivalent on October 26, 2022. The device falls under product code QSD (Posterior Cervical Screw Placement Guide), a Class II device regulated under 21 CFR 888.3075. Mighty Oak Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2022
- Date Received
- January 18, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Posterior Cervical Screw Placement Guide
- Device Class
- Class II
- Regulation Number
- 888.3075
- Review Panel
- OR
- Submission Type
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.