The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Humeral Head Plate With Angular Stability.
| Device ID | K051412 |
| 510k Number | K051412 |
| Device Name: | HUMERAL HEAD PLATE 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 | 2005-05-31 |
| Decision Date | 2005-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120116972174 | K051412 | 000 |
| 09120069812459 | K051412 | 000 |
| 09120047297353 | K051412 | 000 |
| 09120034302985 | K051412 | 000 |
| 09120069812442 | K051412 | 000 |
| 09120047297360 | K051412 | 000 |
| 09120047297346 | K051412 | 000 |
| 09120034307430 | K051412 | 000 |
| 09120034305184 | K051412 | 000 |
| 09120034305177 | K051412 | 000 |
| 09120069813562 | K051412 | 000 |
| 09120069813579 | K051412 | 000 |
| 09120116972167 | K051412 | 000 |
| 09120116972150 | K051412 | 000 |
| 09120116972143 | K051412 | 000 |
| 09120069813630 | K051412 | 000 |
| 09120069813623 | K051412 | 000 |
| 09120069813616 | K051412 | 000 |
| 09120069813609 | K051412 | 000 |
| 09120069813593 | K051412 | 000 |
| 09120069813586 | K051412 | 000 |
| 09120034302992 | K051412 | 000 |