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

Bone Cement, Antibiotic

21 CFR 888.3027 / Orthopedic
FDA source (opens on fda.gov)

MBB is the FDA product code for Bone Cement, Antibiotic, a class II device type, regulated under 21 CFR 888.3027. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
MBB
Device name
Bone Cement, Antibiotic
Regulation
21 CFR 888.3027
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
19
Ingested recalls
7

Clearances, product code MBB

By decision year
19 clearances under product code MBB with a decision year between 2005 and 2025, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MBB by decision year
YearClearances
20051
20061
20071
20081
20141
20151
20162
20171
20192
20201
20211
20223
20242
20251

Applicants with the most clearances

Product code MBB
Applicants holding the most 510(k) clearances under product code MBB
ApplicantClearances
Zimmer GmbH7
Depuy Orthopaedics Inc.3
G21, S.r.l.3
G21, S.r.l.2
Biomet Manufacturing Corp1
Howmedica Osteonics Corp1
Osartis GmbH1
Teknimed SAS1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order