Anterior Staple As Supplemental Fixation For Fusion
The Anterior Staple as Supplemental Fixation for Fusion is an orthopedic implant device designed for use as anterior cervical supplemental fixation to support spinal fusion procedures. It is an FDA Class 2 device regulated under 21 CFR 888.3060, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PHQ, and it is flagged as an implant due to its surgical placement in the cervical spine. This device is not life-sustaining.
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Basic Information
- Product Code
- PHQ
- Device Class
- FDA class 2
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Anterior cervical device for supplemental fixation to support a fusion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.