The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Alta Dome And Plunger (mec Hip Bolt).
| Device ID | K961213 |
| 510k Number | K961213 |
| Device Name: | ALTA DOME AND PLUNGER (MEC HIP BOLT) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-28 |
| Decision Date | 1996-06-13 |
| Summary: | summary |