DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING

Plate, Fixation, Bone

I.T.S. GMBH

The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for Distal Ulna Locking Plate (dul), Ulna Osteotomy Locking Plate (uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking.

Pre-market Notification Details

Device IDK130008
510k NumberK130008
Device Name:DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
ClassificationPlate, Fixation, Bone
Applicant I.T.S. GMBH 3150 E. 200TH STREET Prior Lake,  MN  55372
ContactAl Lippincott
CorrespondentAl Lippincott
I.T.S. GMBH 3150 E. 200TH STREET Prior Lake,  MN  55372
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-02
Decision Date2013-06-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09120047306710 K130008 000
09120047296486 K130008 000
09120047296493 K130008 000
09120047296509 K130008 000
09120047296516 K130008 000
09120047296523 K130008 000
09120047296530 K130008 000
09120047297728 K130008 000
09120047297735 K130008 000
09120047306673 K130008 000
09120047306680 K130008 000
09120047306697 K130008 000
09120034305344 K130008 000

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