I.T.S. GmbH · Class II · Cleared Jun 25, 2013
| K-number | K130008 |
| Device name | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING |
| Applicant | I.T.S. GmbH |
| Product code | HRS |
| Device class | Class II |
| Decision date | Jun 25, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov