The following data is part of a premarket notification filed by Efratgo, Ltd. Hi Tech Bio-surgical with the FDA for Gotfried Percutaneous Compression Plating System.
| Device ID | K983814 |
| 510k Number | K983814 |
| Device Name: | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | EFRATGO, LTD. HI TECH BIO-SURGICAL 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan EFRATGO, LTD. HI TECH BIO-SURGICAL 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1999-01-14 |
| Summary: | summary |