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

Screw, Fixation, Bone, Non-Spinal, Metallic

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

NDJ is the FDA product code for Screw, Fixation, Bone, Non-Spinal, Metallic, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold no 510(k) clearances under this code and 13 recalls.

Classification record

Product code
NDJ
Device name
Screw, Fixation, Bone, Non-Spinal, Metallic
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
0
Ingested recalls
13

Companies listing this code with FDA

Companies whose registered establishments list this code