The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hoffmann Ii Miami Post.
| Device ID | K983419 |
| 510k Number | K983419 |
| Device Name: | HOFFMANN II MIAMI POST |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Joseph Volpe |
| Correspondent | Joseph Volpe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-11-25 |
| Summary: | summary |