ASCENSION NUGRIP CMC IMPLANT


Device Classification Name

prosthesis, wrist, carpal trapezium

510(k) Number K112278
Device Name ASCENSION NUGRIP CMC IMPLANT
Applicant
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Applicant Contact bradley w strasser
Correspondent
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Correspodent Contact bradley w strasser
Regulation Number 888.3770
Classification Product Code
KYI  
Date Received 08/09/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No