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510(k) K132104

ELIBRA SOFT-TISSUE FORCE SENSOR by Kamm & Associates — Product Code ONN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2014
Date Received
July 8, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Orthopedic Joint Assessment Aid
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Measurement and interpretation of orthopedic joint information.

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