The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Cortical Bone Screw.
| Device ID | K915448 |
| 510k Number | K915448 |
| Device Name: | CORTICAL BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Diane Patton |
| Correspondent | Diane Patton DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-02-28 |