ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K121636
Device Name ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
Applicant
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175
el dorado hills, 
CA 
95762

Applicant Contact prakash pai
Correspondent
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175
el dorado hills, 
CA 
95762

Correspodent Contact prakash pai
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received 06/04/2012
Decision Date 10/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No