The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Fr.o.h. Calcaneus Repair System.
| Device ID | K051642 |
| 510k Number | K051642 |
| Device Name: | FR.O.H. CALCANEUS REPAIR SYSTEM |
| Classification | Plate, Fixation, Bone, Non-spinal, Metallic |
| 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 | NDF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120069812862 | K051642 | 000 |
| 09120069812855 | K051642 | 000 |
| 09120069812848 | K051642 | 000 |
| 09120069812831 | K051642 | 000 |