PMA P000058S069

Device

INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion Device

Applicant

Medtronic Sofamor Danek USA, Inc.

PMA number

P000058

Supplement

S069

Product code

NEK

Decision date

2018-08-29

Classification

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

Generic name

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction

Approval order statement

Add a pump to aid in manufacture.

Summary

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