MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE…


Device Classification Name

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

510(k) Number K112285
Device Name MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE…
Applicant
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175 & 180
el dorado hills, 
CA 
95762

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

Correspodent Contact dennis h crane
Regulation Number 888.3560
Classification Product Code
JWH  
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