The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for I.t.s. Pelvic Reconstruction System.
| Device ID | K063166 | 
| 510k Number | K063166 | 
| Device Name: | I.T.S. PELVIC RECONSTRUCTION SYSTEM | 
| Classification | Plate, Fixation, Bone | 
| Applicant | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 | 
| Contact | Al Lippincott | 
| Correspondent | Al Lippincott I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 | 
| Product Code | HRS | 
| Subsequent Product Code | HWC | 
| Subsequent Product Code | JDW | 
| CFR Regulation Number | 888.3030 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2006-10-18 | 
| Decision Date | 2006-12-22 | 
| Summary: | summary |