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FDA 510(k)

GREAT TOE IMPLANT

K-Number: K021063 · 2002-07-01

ApplicantSignal Medical Corp.
Decision Date2002-07-01
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GREAT TOE IMPLANT 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 2002-07-01 under 510(k) number K021063. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREAT TOE IMPLANT?

GREAT TOE IMPLANT is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Signal Medical Corp.. The 510(k) number is K021063.

When did GREAT TOE IMPLANT receive FDA 510(k) clearance?

GREAT TOE IMPLANT received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021063.

Who is the listed applicant for GREAT TOE IMPLANT?

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 GREAT TOE IMPLANT?

The FDA product code for GREAT TOE IMPLANT is KWD.

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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)K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMK043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTK022382RHS ACETABULAR COMPONENTK981302SMC 28MM CERAMIC FEMORAL HEADS

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Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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