FIREFLY® Pedicle Screw Navigation Guide— 510(k) K162419
Substantially EquivalentMighty Oak Medical, Inc.
FDA 510(k) clearance K162419 for FIREFLY® Pedicle Screw Navigation Guide, Substantially Equivalent on 2016-10-28. Applicant: Mighty Oak Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Mighty Oak Medical, Inc.
- Product code
- Code PQC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code PQC
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- K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
- K181883 — FIREFLY® Midline Navigation Guide
More clearances from Mighty Oak Medical, Inc.
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