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FDA 510(k)

OVOMotion Shoulder Arthroplasty System

K-Number: K173964 · 2018-04-18

ApplicantArthrosurface, Inc.
Decision Date2018-04-18
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OVOMotion Shoulder Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-04-18 under 510(k) number K173964. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVOMotion Shoulder Arthroplasty System?

OVOMotion Shoulder Arthroplasty System is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K173964.

When did OVOMotion Shoulder Arthroplasty System receive FDA 510(k) clearance?

OVOMotion Shoulder Arthroplasty System received FDA 510(k) clearance on 2018-04-18, under 510(k) number K173964.

Who is the listed applicant for OVOMotion Shoulder Arthroplasty System?

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

What is the FDA product code for OVOMotion Shoulder Arthroplasty System?

The FDA product code for OVOMotion Shoulder Arthroplasty System is HSD.

Other records listing Arthrosurface, Inc. 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.

K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK190261BOSS Toe Fixation SystemK181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemK172383Arthrosurface Bone ScrewsK170440KISSloc Suture System

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Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH

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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