510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PHQClass II

Anterior Staple As Supplemental Fixation For Fusion

21 CFR 888.3060 / Orthopedic
FDA source (opens on fda.gov)

PHQ is the FDA product code for Anterior Staple As Supplemental Fixation For Fusion, a class II device type, regulated under 21 CFR 888.3060. FDA's definition for this code reads: "Anterior cervical device for supplemental fixation to support a fusion". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHQ
Device name
Anterior Staple As Supplemental Fixation For Fusion
FDA definition
Anterior cervical device for supplemental fixation to support a fusion.
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PHQ

By decision year
2 clearances under product code PHQ with a decision year between 2014 and 2021, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PHQ by decision year
YearClearances
20141
20211

Applicants with the most clearances

Product code PHQ
Applicants holding the most 510(k) clearances under product code PHQ
ApplicantClearances
Medicrea International1
Pressio, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code