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FDA PMA

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction

PMA Number: P000054 · 2026-08-26

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2026-08-26
PMA NumberP000054
Product CodeMPW
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-08-26. The device is classified under product code MPW. It was reviewed by the OR advisory panel.

Frequently Asked Questions

What is the Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction?

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Medtronic Sofamor Danek USA, Inc..

When did Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction receive FDA 510(k) clearance?

The clearance date for Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction can be found in the official FDA records.

Who is the listed applicant for Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction?

The FDA product code for Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction is MPW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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