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FDA 510(k)

METATARSAL DECOMPRESSION IMPLANT, MODEL 100

K-Number: K090127 · 2009-05-01

ApplicantSolana Surgical, LLC
Decision Date2009-05-01
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METATARSAL DECOMPRESSION IMPLANT, MODEL 100 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 2009-05-01 under 510(k) number K090127. 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 METATARSAL DECOMPRESSION IMPLANT, MODEL 100?

METATARSAL DECOMPRESSION IMPLANT, MODEL 100 is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Solana Surgical, LLC. The 510(k) number is K090127.

When did METATARSAL DECOMPRESSION IMPLANT, MODEL 100 receive FDA 510(k) clearance?

METATARSAL DECOMPRESSION IMPLANT, MODEL 100 received FDA 510(k) clearance on 2009-05-01, under 510(k) number K090127.

Who is the listed applicant for METATARSAL DECOMPRESSION IMPLANT, MODEL 100?

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 METATARSAL DECOMPRESSION IMPLANT, MODEL 100?

The FDA product code for METATARSAL DECOMPRESSION IMPLANT, MODEL 100 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.

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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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