510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KTWClass II

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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

KTW is the FDA product code for Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 57 recalls.

Classification record

Product code
KTW
Device name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
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
38
Ingested recalls
57

Clearances, product code KTW

By decision year
38 clearances under product code KTW with a decision year between 1978 and 2019, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KTW by decision year
YearClearances
19781
19791
19822
19842
19851
19862
19871
19891
19901
19911
19921
19931
19941
19951
19971
19981
19993
20002
20013
20023
20061
20082
20121
20161
20172
20191

Applicants with the most clearances

Product code KTW
Applicants holding the most 510(k) clearances under product code KTW
ApplicantClearances
Synthes (USA) Products LLC8
Advanced Orthopaedic Solutions, Inc.2
Alliance Medical Corp.2
Zimmer GmbH2
Buckman Co., Inc.2
Howmedica Corp.2
Mecron Medical Products, Inc.2
Orthofix SRL2
Turnkey Intergration USA, Inc.2
Advanced Orthopaedic Solutions, Inc. (Aos)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order