CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD


Device Classification Name

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

510(k) Number K110542
Device Name CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
Applicant
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way, suite 100
el dorado hills, 
CA 
95762 -9623

Applicant Contact matthew hull
Correspondent
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way, suite 100
el dorado hills, 
CA 
95762 -9623

Correspodent Contact matthew hull
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received 02/24/2011
Decision Date 04/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No