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

Plate, Fixation, Bone, Non-Spinal, Metallic

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

NDF is the FDA product code for Plate, Fixation, Bone, Non-Spinal, Metallic, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NDF
Device name
Plate, Fixation, Bone, Non-Spinal, Metallic
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
3
Ingested recalls
1

Clearances, product code NDF

By decision year
3 clearances under product code NDF with a decision year between 2001 and 2005, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDF by decision year
YearClearances
20011
20021
20051

Applicants with the most clearances

Product code NDF
Applicants holding the most 510(k) clearances under product code NDF
ApplicantClearances
Ebi, LLC2
I.T.S. Implantat-Technologie-Systeme GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code