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FDA 510(k)

GRAVITY™ Syndesmosis LP

K-Number: K170249 · 2017-06-30

ApplicantWrightmedicaltechnologyinc
Decision Date2017-06-30
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GRAVITY™ Syndesmosis LP is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K170249. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAVITY™ Syndesmosis LP?

GRAVITY™ Syndesmosis LP is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K170249.

When did GRAVITY™ Syndesmosis LP receive FDA 510(k) clearance?

GRAVITY™ Syndesmosis LP received FDA 510(k) clearance on 2017-06-30, under 510(k) number K170249.

Who is the listed applicant for GRAVITY™ Syndesmosis LP?

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™ Syndesmosis LP?

The FDA product code for GRAVITY™ Syndesmosis LP is HTN.

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, 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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