The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Distal Humeral Plates With Angular Stability.
| Device ID | K080184 |
| 510k Number | K080184 |
| Device Name: | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY |
| Classification | Plate, Fixation, Bone |
| Applicant | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Contact | Al Lippinocott |
| Correspondent | Al Lippinocott I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. 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 | 2008-01-25 |
| Decision Date | 2008-03-26 |
| Summary: | summary |