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FDA 510(k)

SYGNAL DBM

K-Number: K080405 · 2008-08-28

ApplicantMusculoskeletal Transplant Foundation
Decision Date2008-08-28
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYGNAL DBM 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 2008-08-28 under 510(k) number K080405. 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 SYGNAL DBM?

SYGNAL DBM is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K080405.

When did SYGNAL DBM receive FDA 510(k) clearance?

SYGNAL DBM received FDA 510(k) clearance on 2008-08-28, under 510(k) number K080405.

Who is the listed applicant for SYGNAL DBM?

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 SYGNAL DBM?

The FDA product code for SYGNAL DBM 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.

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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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