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

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

21 CFR 888.3560 / Orthopedic
FDA source (opens on fda.gov)

MBV is the FDA product code for Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer, a class II device type, regulated under 21 CFR 888.3560. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MBV
Device name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
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
14
Ingested recalls
1

Clearances, product code MBV

By decision year
14 clearances under product code MBV with a decision year between 1978 and 2001, 1983 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MBV by decision year
YearClearances
19782
19811
19821
19836
19861
19871
19891
20011

Applicants with the most clearances

Product code MBV
Applicants holding the most 510(k) clearances under product code MBV
ApplicantClearances
Depuy, Inc.5
Advanced Biosearch Assn.2
Protek, Inc.2
Richard'S Medical Equip., Inc.2
Richards Medical Co., Inc.2
Zimmer GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order