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SYGNAL DBM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073329

by Musculoskeletal Transplant Foundation

Identifiers

510(k) Number
K073329 FDA 510(k)
FDA Product Code
MBP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SYGNAL DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is a demineralized bone matrix product designed to aid in bone regeneration and healing. The device can be used alone or as an extender in the posterolateral spine with bone marrow.

SYGNAL DBM is manufactured by the Musculoskeletal Transplant Foundation and was cleared through the FDA 510(k) pathway on February 28, 2008. It is classified as a Class 2 medical device under product code MBP. The device is supplied in various sizes and is intended for use in orthopedic applications.

Frequently asked questions

What is SYGNAL DBM used for?

SYGNAL DBM is used as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, aiding in bone regeneration and healing.

How is SYGNAL DBM supplied?

SYGNAL DBM is supplied in various sizes, intended for use in orthopedic applications, and can be used alone or as an extender in the posterolateral spine with bone marrow.

Is SYGNAL DBM a single-use or reusable device?

The description does not explicitly state whether SYGNAL DBM is single-use or reusable, but as a bone void filler, it is typically used once for each application.

What is the regulatory classification of SYGNAL DBM?

SYGNAL DBM is classified as a Class 2 medical device under product code MBP, and was cleared through the FDA 510(k) pathway.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SYGNAL DBM by MUSCULOSKELETAL TRANSPLANT FOUNDATION | FDA 510 (k) Summary, Sygnal DBM - Musculoskeletal Transplant Foundation | FDA Reference, Sygnal DBM - Musculoskeletal Transplant Foundation | FDA Reference

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Musculoskeletal Transplant Foundation

Sources (1)

  • FDA 510(k) K073329 24 fields · synced Oct 6, 2026