FREEDOM PCK COMPONENTS

Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K131481
Device Name FREEDOM PCK COMPONENTS
Applicant
MAXX ORTHOPEDICS, INC.
531 plymouth rd., suite 526
plymouth meeting, 
PA 
19462

Applicant Contact nach dave
Correspondent
MAXX ORTHOPEDICS, INC.
531 plymouth rd., suite 526
plymouth meeting, 
PA 
19462

Correspodent Contact nach dave
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/22/2013
Decision Date 02/21/2014
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No