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FDA 510(k)

SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM

K-Number: K051510 · 2006-03-22

ApplicantSignal Medical Corp.
Decision Date2006-03-22
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corp.. It received FDA 510(k) clearance on 2006-03-22 under 510(k) number K051510. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM?

SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-22. The listed applicant is Signal Medical Corp.. The 510(k) number is K051510.

When did SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM receive FDA 510(k) clearance?

SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM received FDA 510(k) clearance on 2006-03-22, under 510(k) number K051510.

Who is the listed applicant for SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM?

The FDA 510(k) record lists Signal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM?

The FDA product code for SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM is MBH.

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Other records listing Signal Medical Corp. 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.

K100370SYMMETRIC TOTAL KNEE AGUMENTSK073674BONE FIXATION WIRE (KIRSCHNER WIRE)K043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTK022382RHS ACETABULAR COMPONENTK021063GREAT TOE IMPLANTK981302SMC 28MM CERAMIC FEMORAL HEADS

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Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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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