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 |