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510(k) Data Aggregation

K Number

Device Name

EVOLVE EPS SYSTEM

Manufacturer

WRIGHT MEDICAL TECHNOLOGY, INC.

Date Cleared

2008-07-03

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The EVOLVE® EPS System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula.

Device Description

The design features of the EVOLVE® EPS System are described below.

Consists of a variety of pre-contoured plate geometrics .
Plates feature compression slots and locking screw holes ●
Manufactured from Stainless Steel ●
Screws are available in both locking ar d non-locking designs .
Screws are available in 2 diameters and. 18 lengths .

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