The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Leibinger Imf Screw.
| Device ID | K963030 |
| 510k Number | K963030 |
| Device Name: | LEIBINGER IMF SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Andrew B Rogers |
| Correspondent | Andrew B Rogers HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1997-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34546540227622 | K963030 | 000 |
| 34546540227615 | K963030 | 000 |
| 34546540227608 | K963030 | 000 |