HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON


Device Classification Name

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

510(k) Number K111472
Device Name HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
Applicant
TGM MEDICAL
5145 golden foothill parkway
suite 175 & 180
el dorado, 
CA 
95762

Applicant Contact dennis h crane
Correspondent
TGM MEDICAL
5145 golden foothill parkway
suite 175 & 180
el dorado, 
CA 
95762

Correspodent Contact dennis h crane
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 05/27/2011
Decision Date 09/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No