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.
| Device ID | K130008 | 
| 510k Number | K130008 | 
| Device Name: | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING | 
| Classification | Plate, Fixation, Bone | 
| Applicant | I.T.S. GMBH 3150 E. 200TH STREET Prior Lake, MN 55372 | 
| Contact | Al Lippincott | 
| Correspondent | Al Lippincott I.T.S. GMBH 3150 E. 200TH STREET Prior Lake, MN 55372 | 
| Product Code | HRS | 
| CFR Regulation Number | 888.3030 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2013-01-02 | 
| Decision Date | 2013-06-25 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 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 |