GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)


Device Classification Name

plate, bone, growth control, pediatric, epiphysiodesis

510(k) Number K110805
Device Name GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
Applicant
ORTHOFIX INC.
3451 plano parkway
lewisville, 
TX 
75056

Applicant Contact mary biggers
Correspondent
ORTHOFIX INC.
3451 plano parkway
lewisville, 
TX 
75056

Correspodent Contact mary biggers
Regulation Number 888.3030
Classification Product Code
OBT  
Date Received 03/23/2011
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No