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

Total Shoulder Arthroplasty System

21 CFR 888.3660 / Orthopedic
FDA source (opens on fda.gov)

QHQ is the FDA product code for Total Shoulder Arthroplasty System, a class II device type, regulated under 21 CFR 888.3660. FDA's definition for this code reads: "To treat pain and lack of function in the shoulder". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QHQ
Device name
Total Shoulder Arthroplasty System
FDA definition
To treat pain and lack of function in the shoulder.
Regulation
21 CFR 888.3660
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
1
Ingested recalls
1

Clearances, product code QHQ

By decision year
1 clearance under product code QHQ with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QHQ by decision year
YearClearances
20191

Applicants with the most clearances

Product code QHQ
Applicants holding the most 510(k) clearances under product code QHQ
ApplicantClearances
Arthrex GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order