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510(k) K132104

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

K132104 is an FDA 510(k) premarket notification submitted by Kamm & Associates for the device "ELIBRA SOFT-TISSUE FORCE SENSOR". The FDA issued a decision of Substantially Equivalent on March 21, 2014. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560.

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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FDA data resources