The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Epiphysis Screw.
| Device ID | K043410 |
| 510k Number | K043410 |
| Device Name: | EPIPHYSIS SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-02-24 |
| Summary: | summary |