The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for I.t.s. Hand Locking Plates System - Hls.
| Device ID | K142418 |
| 510k Number | K142418 |
| Device Name: | I.T.S. Hand Locking Plates System - HLS |
| Classification | Plate, Fixation, Bone |
| Applicant | I.T.S. GmbH Autal 28 Lassinitzhoehe/graz, AT A-8301 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH. ST. Prior Lake, MN 55372 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2014-09-26 |
| Summary: | summary |