The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Claviculaplate With Angular Stablity Bone Plate System.
| Device ID | K050852 |
| 510k Number | K050852 |
| Device Name: | CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Contact | Albert Lippincott |
| Correspondent | Albert 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 | 2005-04-04 |
| Decision Date | 2005-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120069812237 | K050852 | 000 |
| 09120069811964 | K050852 | 000 |
| 09120069811940 | K050852 | 000 |
| 09120069811926 | K050852 | 000 |
| 09120069811919 | K050852 | 000 |
| 09120069811506 | K050852 | 000 |
| 09120034309670 | K050852 | 000 |
| 09120034305214 | K050852 | 000 |
| 09120034305191 | K050852 | 000 |
| 09120034304415 | K050852 | 000 |
| 09120069812220 | K050852 | 000 |
| 09120069812244 | K050852 | 000 |
| 09120069811971 | K050852 | 000 |
| 09120069811957 | K050852 | 000 |
| 09120069811933 | K050852 | 000 |
| 09120034309793 | K050852 | 000 |
| 09120034305238 | K050852 | 000 |
| 09120034305221 | K050852 | 000 |
| 09120034305207 | K050852 | 000 |
| 09120034304507 | K050852 | 000 |
| 09120069812251 | K050852 | 000 |
| 09120034304385 | K050852 | 000 |