Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973683
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K973683
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
EBI ELECTRO BIOLOGY
6 UPPER POND RD.
PARSIPPANY, NJ 07054-1079 US
Other 510(k) Applications for this Company
Contact
JON CAPAROTTA
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
09/26/1997
Decision Date
12/24/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact