FIREFLY® Cervical Navigation Guide
FDA 510(k) clearance K220132 · decided 2022-10-26
Clearance details
- K-number
- K220132
- Device name
- FIREFLY® Cervical Navigation Guide
- Applicant
- Mighty Oak Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-18
- Decision date
- 2022-10-26
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- QSD
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MySpine Cervical Guides (K231515) | Medacta International S.A. | 2023-12-07 |
Recalls involving this device
No recalls on record reference this clearance.