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FDA 510(k)

LESSER METATARSAL HEAD IMPLANT SYSTEM

K-Number: K131187 · 2013-10-22

ApplicantSolana Surgical, LLC
Decision Date2013-10-22
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LESSER METATARSAL HEAD IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solana Surgical, LLC. It received FDA 510(k) clearance on 2013-10-22 under 510(k) number K131187. 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 LESSER METATARSAL HEAD IMPLANT SYSTEM?

LESSER METATARSAL HEAD IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Solana Surgical, LLC. The 510(k) number is K131187.

When did LESSER METATARSAL HEAD IMPLANT SYSTEM receive FDA 510(k) clearance?

LESSER METATARSAL HEAD IMPLANT SYSTEM received FDA 510(k) clearance on 2013-10-22, under 510(k) number K131187.

Who is the listed applicant for LESSER METATARSAL HEAD IMPLANT SYSTEM?

The FDA 510(k) record lists Solana Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LESSER METATARSAL HEAD IMPLANT SYSTEM?

The FDA product code for LESSER METATARSAL HEAD IMPLANT SYSTEM is KWD.

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Other records listing Solana Surgical, LLC 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.

K132594CROSSCHECK PLATING SYSTEMK124045FUSEFORCE IMPLANT SYSTEMK122738GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SETK120390SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SETK113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETK120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET

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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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