IMPIX SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K072226
Device Name IMPIX SPACER
Applicant
MEDICREA TECHNOLOGIES
1001 oakwood blvd.
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
MEDICREA TECHNOLOGIES
1001 oakwood blvd.
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received 08/10/2007
Decision Date 12/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No