The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica And Howmedica Leibinger Bone Screw Washers.
| Device ID | K980364 |
| 510k Number | K980364 |
| Device Name: | HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Sean Luland |
| Correspondent | Sean Luland HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-04-29 |
| Summary: | summary |