FDA Product Code
FDA Product Code PQC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | 2026-02-25 | Traditional | PDF ↗ |
| K231483 | MySpine Unilateral Guides | Medacta International S.A. | 2023-07-21 | Traditional | PDF ↗ |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) | Medacta International S.A. | 2021-04-06 | Special | PDF ↗ |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA | 2020-10-05 | Traditional | PDF ↗ |
| K181883 | FIREFLY® Midline Navigation Guide | Mighty Oak Medical, Inc. | 2018-10-03 | Traditional | PDF ↗ |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018-07-24 | Traditional | PDF ↗ |
| K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments | Medacta International S.A. | 2018-04-19 | Traditional | PDF ↗ |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016-10-28 | Traditional | PDF ↗ |
Product code PQC · Class II · Orthopedic. Data: openFDA.