The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Alta Tibial/humeral Rod.
| Device ID | K954554 |
| 510k Number | K954554 |
| Device Name: | ALTA TIBIAL/HUMERAL ROD |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-12-13 |