GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD


Device Classification Name

screw, fixation, bone

510(k) Number K103712
Device Name GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact kristine christo
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact kristine christo
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 12/20/2010
Decision Date 03/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No