QSDClass II
Posterior Cervical Screw Placement Guide
21 CFR 888.3075 / Orthopedic
QSD is the FDA product code for Posterior Cervical Screw Placement Guide, a class II device type, regulated under 21 CFR 888.3075. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QSD
- Device name
- Posterior Cervical Screw Placement Guide
- 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.
- Regulation
- 21 CFR 888.3075
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QSD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code QSD| Applicant | Clearances |
|---|---|
| Medacta International SA | 1 |
| Mighty Oak Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.