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

Shoulder Arthroplasty Implantation System

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

QHE is the FDA product code for Shoulder Arthroplasty Implantation System, a class II device type, regulated under 21 CFR 888.3660. FDA's definition for this code reads: "Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components". As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QHE
Device name
Shoulder Arthroplasty Implantation System
FDA definition
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
2

Clearances, product code QHE

By decision year
26 clearances under product code QHE with a decision year between 2019 and 2026, 2023 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code QHE by decision year
YearClearances
20191
20203
20212
20223
20236
20244
20253
20264

Applicants with the most clearances

Product code QHE
Applicants holding the most 510(k) clearances under product code QHE
ApplicantClearances
Materialise N.V.9
Orthosoft Inc (D/B/A Zimmer Cas)6
Arthrex GmbH3
Precision AI Pty Ltd3
Techmah Medical, LLC2
3D-Side1
Lima Corporate S.p.A.1
LinkBio Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order