The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Stalif (tm) C.
| Device ID | K072415 |
| 510k Number | K072415 |
| Device Name: | STALIF (TM) C |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald W Guthner |
| Correspondent | Donald W Guthner SURGICRAFT LTD. 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-28 |
| Decision Date | 2008-01-25 |
| Summary: | summary |