The following data is part of a premarket notification filed by Efratgo, Ltd. Hi Tech Bio-surgical with the FDA for Gotfried Physiological Hip (ph) Nail.
| Device ID | K083648 |
| 510k Number | K083648 |
| Device Name: | GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | EFRATGO, LTD. HI TECH BIO-SURGICAL 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub EFRATGO, LTD. HI TECH BIO-SURGICAL 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-05-14 |
| Summary: | summary |