Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET

K-Number: K122738 · 2012-11-07

ApplicantSolana Surgical, LLC
Decision Date2012-11-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET 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 2012-11-07 under 510(k) number K122738. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET?

GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Solana Surgical, LLC. The 510(k) number is K122738.

When did GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET receive FDA 510(k) clearance?

GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET received FDA 510(k) clearance on 2012-11-07, under 510(k) number K122738.

Who is the listed applicant for GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET?

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 GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET?

The FDA product code for GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK124045FUSEFORCE IMPLANT SYSTEMK120390SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SETK120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETK113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET

View all 8 devices →

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

↑