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

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

21 CFR 888.3590 / Orthopedic
FDA source (opens on fda.gov)

HSH is the FDA product code for Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented), a class II device type, regulated under 21 CFR 888.3590. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HSH
Device name
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Regulation
21 CFR 888.3590
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
5
Ingested recalls
0

Clearances, product code HSH

By decision year
5 clearances under product code HSH with a decision year between 2001 and 2008, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HSH by decision year
YearClearances
20011
20021
20031
20061
20081

Applicants with the most clearances

Product code HSH
Applicants holding the most 510(k) clearances under product code HSH
ApplicantClearances
Advanced Bio-Surfaces, Inc.2
Imaging Therapeutics, Inc.1
Osteoimplant Technology, Inc.1
Sulzer Orthopedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code