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FDA 510(k)

FUSEFORCE IMPLANT SYSTEM

K-Number: K124045 · 2013-07-10

ApplicantSolana Surgical, LLC
Decision Date2013-07-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUSEFORCE 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 2013-07-10 under 510(k) number K124045. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSEFORCE IMPLANT SYSTEM?

FUSEFORCE IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-10. The listed applicant is Solana Surgical, LLC. The 510(k) number is K124045.

When did FUSEFORCE IMPLANT SYSTEM receive FDA 510(k) clearance?

FUSEFORCE IMPLANT SYSTEM received FDA 510(k) clearance on 2013-07-10, under 510(k) number K124045.

Who is the listed applicant for FUSEFORCE 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 FUSEFORCE IMPLANT SYSTEM?

The FDA product code for FUSEFORCE IMPLANT SYSTEM is JDR.

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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 SYSTEMK131187LESSER METATARSAL HEAD 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: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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