PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES


Device Classification Name

prosthesis, ankle, semi-constrained, cemented, metal/polymer

510(k) Number K110360
Device Name PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact sarah holtgrewe
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact sarah holtgrewe
Regulation Number 888.3110
Classification Product Code
HSN  
Subsequent Product Code
OYK  
Date Received 02/08/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No