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

Fastener, Fixation, Nondegradable, Soft Tissue

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

MBI is the FDA product code for Fastener, Fixation, Nondegradable, Soft Tissue, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 601 510(k) clearances under this code, the most recent dated , and 113 recalls.

Classification record

Product code
MBI
Device name
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
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
604
Ingested recalls
113

Clearances, product code MBI

By decision year
604 clearances under product code MBI with a decision year between 1995 and 2026, 2023 the highest year at 52.
Show the numbers
510(k) clearances under FDA product code MBI by decision year
YearClearances
19959
199619
199727
199825
199910
20004
200113
20024
20031
20047
20055
20065
200716
200810
200919
201017
201130
201224
201331
201423
201523
201617
201717
201816
201931
202035
202118
202219
202352
202422
202527
202628

Applicants with the most clearances

Product code MBI
Applicants holding the most 510(k) clearances under product code MBI
ApplicantClearances
Arthrex GmbH52
ArthroCare Corporation31
Smith & Nephew, Inc.29
Parcus Medical, L.L.C.23
Innovasive Devices, Inc.22
Riverpoint Medical, LLC22
Stryker Corp.21
ConMed Corporation16
Medacta International SA15
Cayenne Medical Inc.14

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 235 companies shown, in name order