The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Olecranonplate With Angular Stability.
Device ID | K052368 |
510k Number | K052368 |
Device Name: | OLECRANONPLATE 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 Lippincott |
Correspondent | Al Lippincott 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 | 2005-08-29 |
Decision Date | 2005-10-17 |
Summary: | summary |