The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Auto-drive Bone Screw.
| Device ID | K974785 |
| 510k Number | K974785 |
| Device Name: | AUTO-DRIVE BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Contact | Bruce Horowitz |
| Correspondent | Bruce Horowitz OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-03-18 |
| Summary: | summary |