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

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

21 CFR 888.3690 / Orthopedic
FDA source (opens on fda.gov)

HSD is the FDA product code for Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a class II device type, regulated under 21 CFR 888.3690. As of , FDA records hold 71 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
HSD
Device name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
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
71
Ingested recalls
19

Clearances, product code HSD

By decision year
71 clearances under product code HSD with a decision year between 1979 and 2024, 2006 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code HSD by decision year
YearClearances
19791
19802
19821
19872
19881
19916
19941
19952
19962
19971
19981
19992
20004
20014
20021
20034
20042
20052
20068
20074
20083
20112
20122
20134
20141
20163
20181
20202
20221
20241

Applicants with the most clearances

Product code HSD
Applicants holding the most 510(k) clearances under product code HSD
ApplicantClearances
Howmedica Osteonics Corp6
Arthrex GmbH5
Zimmer GmbH5
Depuy Orthopaedics Inc.4
Exactech, Inc.4
Howmedica Corp.3
Intermedics Orthopedics3
TORNIER Inc.3
Arthrosurface, Inc.2
Ascension Orthopedics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 184 companies shown, in name order