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

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Unknown
FDA source (opens on fda.gov)

NEK is the FDA product code for Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction, a class III device type. As of , FDA records hold no 510(k) clearances under this code and 8 recalls.

Classification record

Product code
NEK
Device name
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
8

Companies listing this code with FDA

Companies whose registered establishments list this code