510(k) K052005

R&R EXTERNAL FIXATION SYSTEM by R&R Medical, Inc. — Product Code KTT

K052005 is an FDA 510(k) premarket notification submitted by R&R Medical, Inc. for the device "R&R EXTERNAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 6, 2005. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. R&R Medical, Inc. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 6, 2005
Date Received
Jul 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type
510(k)