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

Fastener, Fixation, Biodegradable, Soft Tissue

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

MAI is the FDA product code for Fastener, Fixation, Biodegradable, Soft Tissue, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 221 510(k) clearances under this code, the most recent dated , and 97 recalls.

Classification record

Product code
MAI
Device name
Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
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
221
Ingested recalls
97

Clearances, product code MAI

By decision year
221 clearances under product code MAI with a decision year between 1994 and 2026, 1999 the highest year at 19.
Show the numbers
510(k) clearances under FDA product code MAI by decision year
YearClearances
19941
19953
19967
19979
19987
199919
200010
200112
20033
20046
20055
20064
20074
20083
20099
20104
20119
20126
20136
20144
20155
20163
20179
201813
20199
20209
20218
20226
20238
20247
20258
20265

Applicants with the most clearances

Product code MAI
Applicants holding the most 510(k) clearances under product code MAI
ApplicantClearances
Arthrex GmbH46
DePuy Mitek, Inc.23
Smith & Nephew, Inc.13
Bionx Implants, Inc.11
Linvatec Corporation11
Medos International SARL8
Acuitive Technologies5
Aju Medical Co., Ltd.5
TORNIER Inc.5
Zimmer GmbH5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order