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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameOP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
Classification Nametransilluminator, fiber optic
Generic Nametransilluminator, fiber optic
Regulation Number874.4350
Applicant
Olympus Biotech Corporation
35 s. st.
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS021
Date Received03/14/2012
Decision Date07/26/2013
Product Code
MQW[ Registered Establishments with MQW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for use of an alternate gamma irradiation terminal sterilization supplier, as well as modifications to the details of the irradiation sterilization processing, auditing and release testing.
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