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FDA 510(k)

CROSSCHECK PLATING SYSTEM

K-Number: K132594 · 2013-12-13

ApplicantSolana Surgical, LLC
Decision Date2013-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CROSSCHECK PLATING 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 2013-12-13 under 510(k) number K132594. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSCHECK PLATING SYSTEM?

CROSSCHECK PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Solana Surgical, LLC. The 510(k) number is K132594.

When did CROSSCHECK PLATING SYSTEM receive FDA 510(k) clearance?

CROSSCHECK PLATING SYSTEM received FDA 510(k) clearance on 2013-12-13, under 510(k) number K132594.

Who is the listed applicant for CROSSCHECK PLATING 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 CROSSCHECK PLATING SYSTEM?

The FDA product code for CROSSCHECK PLATING SYSTEM is HRS.

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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.

K131187LESSER METATARSAL HEAD IMPLANT 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: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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