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 |