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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09120034305337 | K080184 | 000 |
09120034305245 | K080184 | 000 |
09120034305252 | K080184 | 000 |
09120034305283 | K080184 | 000 |
09120034305290 | K080184 | 000 |
09120034305306 | K080184 | 000 |
09120034305313 | K080184 | 000 |
09120034304910 | K080184 | 000 |
09120034304927 | K080184 | 000 |
09120034304934 | K080184 | 000 |
09120034305269 | K080184 | 000 |
09120034305276 | K080184 | 000 |
09120034305320 | K080184 | 000 |
09120034304903 | K080184 | 000 |