Product Code: PHQ FDA class 2 21 CFR 888.3060

Anterior Staple As Supplemental Fixation For Fusion

Orthopedic

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.

510(k)s
2
FEI Numbers
6
Registration Numbers
6
Unique Applicants
2
Years Active
7

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Anterior cervical device for supplemental fixation to support a fusion.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K200301 UNiTi ACDF Implant System
K133906 C-JAWS CERVICAL COMPRESSIVE STAPLE

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.