PHQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anterior Staple As Supplemental Fixation For Fusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Anterior cervical device for supplemental fixation to support a fusion.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UNiTi ACDF Implant System (K200301) | Pressio, Inc. | 2021-02-03 |
| C-JAWS CERVICAL COMPRESSIVE STAPLE (K133906) | Medicrea International | 2014-07-24 |
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