The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Luhr Mandibular Compression-screw System.
| Device ID | K761228 |
| 510k Number | K761228 |
| Device Name: | LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | HOWMEDICA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-10 |
| Decision Date | 1976-12-15 |