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FDA 510(k)

DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE

K-Number: K080399 · 2008-10-10

ApplicantMusculoskeletal Transplant Foundation
Decision Date2008-10-10
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K080399. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE?

DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K080399.

When did DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE receive FDA 510(k) clearance?

DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE received FDA 510(k) clearance on 2008-10-10, under 510(k) number K080399.

Who is the listed applicant for DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE?

The FDA 510(k) record lists Musculoskeletal Transplant Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE?

The FDA product code for DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE is MBP.

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Other records listing Musculoskeletal Transplant Foundation as applicant

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.

K181633MTF Pre-Sutured TendonK121313MTF NEW BONE VOID FILLERK120479MTF FASCIAK113167MTF NEW BONE VOILD FILLERK110003MTF NEW BONE VOID FILLERK103784DBX DEMINERALIZED BONE MATRIX PUTTY

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Related Devices (Code: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences

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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