TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT


Device Classification Name

prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

510(k) Number K121509
Device Name TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
Applicant
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175 & 180
el dorado hills, 
CA 
95762

Applicant Contact prakash pai
Correspondent
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175 & 180
el dorado hills, 
CA 
95762

Correspodent Contact prakash pai
Regulation Number 888.3390
Classification Product Code
KWY  
Date Received 05/21/2012
Decision Date 11/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No