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Shoulder / Rotator cuff / Humerus / Glenohumeral joint / Upper extremity of humerus / Bone fracture / Glenoid cavity / Orthopedic surgery / Hill–Sachs lesion / Anatomy / Medicine / Human anatomy


K13[removed]Exactecha Equinoxe® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k[removed]k) Summary Sponsor:
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Document Date: 2013-08-06 11:28:40

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City

Gainesville / /

Company

Exactech Inc. / Model Name Equinoxe Reverse Shoulder Manufacturer Exactech Inc / K131575 Trade / KI 110708 Trade / /

Event

FDA Phase / /

Facility

Court Gainesville / Drog Admnisttration Document Control Center / /

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IndustryTerm

press-fit applications / metal/polymer / reverse shoulder glenoid baseplate devices / metal / cemented and press-fit applications / predicate devices / bone cement / cited predicate devices / manufacturing / cement / joint metal/polymer / basic fundamental scientific technology / /

Organization

FDA / /

Person

Patrick H-uglhes / Patrick Hughes / Cosmetic Act (Act) / Mark N. Melkerson / /

/

Position

Director / orthopaedic surgeon / humeral head / Major / surgeon / hunmeral head / /

Product

Equinoxe / /

ProvinceOrState

Florida / /

Region

Northwest / /

Technology

radiation / basic fundamental scientific technology / http / /

URL

http /

SocialTag