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FDA 510(k) Application Details - K081041
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K081041
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
G SURGICAL CO., LTD.
152 SOI RAMKHAMHAENG 138
SAPANSUNG
BANGKOK 10240 TH
Other 510(k) Applications for this Company
Contact
DONALD GRAFTON
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2008
Decision Date
06/27/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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