The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Leibinger Self-drilling Screw.
| Device ID | K970912 |
| 510k Number | K970912 |
| Device Name: | LEIBINGER SELF-DRILLING SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Kristyn Waski |
| Correspondent | Kristyn Waski HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327283601 | K970912 | 000 |
| 37613327283595 | K970912 | 000 |