The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Surgicraft Screw Fixation System.
| Device ID | K080447 |
| 510k Number | K080447 |
| Device Name: | SURGICRAFT SCREW FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-06-13 |
| Summary: | summary |