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FDA 510(k)

GRAVITY™ Soft Tissue Repair System

K-Number: K170642 · 2017-08-22

ApplicantWrightmedicaltechnologyinc
Decision Date2017-08-22
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAVITY™ Soft Tissue Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K170642. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAVITY™ Soft Tissue Repair System?

GRAVITY™ Soft Tissue Repair System is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K170642.

When did GRAVITY™ Soft Tissue Repair System receive FDA 510(k) clearance?

GRAVITY™ Soft Tissue Repair System received FDA 510(k) clearance on 2017-08-22, under 510(k) number K170642.

Who is the listed applicant for GRAVITY™ Soft Tissue Repair System?

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

What is the FDA product code for GRAVITY™ Soft Tissue Repair System?

The FDA product code for GRAVITY™ Soft Tissue Repair System is GAT.

Related Clinical Trials

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NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETEDNCT06638138Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle InstabilityCOMPLETEDNCT06710795AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia RepairACTIVE_NOT_RECRUITINGNCT06829667Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle InstabilityCOMPLETEDNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07649434Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal HerniaNOT_YET_RECRUITING

Other records listing Wrightmedicaltechnologyinc as applicant

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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