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

System, External Fixator (With Metallic Invasive Components)

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

NDK is the FDA product code for System, External Fixator (With Metallic Invasive Components), a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NDK
Device name
System, External Fixator (With Metallic Invasive Components)
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
3
Ingested recalls
0

Clearances, product code NDK

By decision year
3 clearances under product code NDK with a decision year between 2010 and 2014, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDK by decision year
YearClearances
20101
20121
20141

Applicants with the most clearances

Product code NDK
Applicants holding the most 510(k) clearances under product code NDK
ApplicantClearances
3D Medical Concepts, LLC1
Christopher D. Endara1
Trimed Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code