QSD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Posterior Cervical Screw Placement Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Medical specialty
- Orthopedic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| MySpine Cervical Guides (K231515) | Medacta International S.A. | 2023-12-07 |
| FIREFLY® Cervical Navigation Guide (K220132) | Mighty Oak Medical, Inc. | 2022-10-26 |
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