The following data is part of a premarket notification filed by Mitek Products with the FDA for Rigidfix Soft Tissue Acl Crosspin System.
| Device ID | K010633 |
| 510k Number | K010633 |
| Device Name: | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-02 |
| Decision Date | 2001-05-09 |
| Summary: | summary |