TRABECULAR METAL (TM) FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111119
Device Name TRABECULAR METAL (TM) FUSION DEVICE
Applicant
ZIMMER SPINE, INC
12708 riata vista circle
suite b-100
austin, 
TX 
78727

Applicant Contact jennifer tribbett
Correspondent
ZIMMER SPINE, INC
12708 riata vista circle
suite b-100
austin, 
TX 
78727

Correspodent Contact jennifer tribbett
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 04/21/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No