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

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

21 CFR 888.3353 / Orthopedic
FDA source (opens on fda.gov)

MAY is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish, a class II device type, regulated under 21 CFR 888.3353. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
MAY
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Regulation
21 CFR 888.3353
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
4
Ingested recalls
19

Clearances, product code MAY

By decision year
4 clearances under product code MAY with a decision year between 2005 and 2013, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MAY by decision year
YearClearances
20051
20091
20111
20131

Applicants with the most clearances

Product code MAY
Applicants holding the most 510(k) clearances under product code MAY
ApplicantClearances
Zimmer GmbH1
Howmedica Osteonics Corp1
Portland Orthopaedics Pty., Ltd.1
Stryker Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order