The following data is part of a premarket notification filed by Johnson & Johnson Company with the FDA for Femoral Intrafix Screw And Sheath.
| Device ID | K063577 |
| 510k Number | K063577 |
| Device Name: | FEMORAL INTRAFIX SCREW AND SHEATH |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-30 |
| Decision Date | 2007-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705013661 | K063577 | 000 |
| 10886705013654 | K063577 | 000 |
| 10886705013647 | K063577 | 000 |
| 10886705013630 | K063577 | 000 |
| 10886705013623 | K063577 | 000 |
| 10886705013616 | K063577 | 000 |