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

Prosthesis, Toe, Hemi-, Phalangeal

21 CFR 888.3730 / Orthopedic
FDA source (opens on fda.gov)

KWD is the FDA product code for Prosthesis, Toe, Hemi-, Phalangeal, a class II device type, regulated under 21 CFR 888.3730. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
KWD
Device name
Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
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
46
Ingested recalls
13

Clearances, product code KWD

By decision year
46 clearances under product code KWD with a decision year between 1979 and 2026, 2007 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KWD by decision year
YearClearances
19791
19861
19871
19881
19911
19971
20011
20023
20031
20043
20064
20075
20083
20092
20101
20111
20123
20132
20161
20171
20192
20201
20211
20222
20231
20241
20261

Applicants with the most clearances

Product code KWD
Applicants holding the most 510(k) clearances under product code KWD
ApplicantClearances
Arthrosurface, Inc.5
Solana Surgical, LLC4
Biopro, Inc.3
Osteomed3
Accufix Surgical, Inc.2
Ascension Orthopedics, Inc.2
Biopoly, LLC2
Orthopro, LLC2
Small Bone Innovations, Inc.2
Sutter Biomedical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order