The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Zeta Multizone Locking Nail System.
| Device ID | K984305 |
| 510k Number | K984305 |
| Device Name: | ZETA MULTIZONE LOCKING NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Joseph Volpe |
| Correspondent | Joseph Volpe HOWMEDICA, INC. 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 | 1998-12-02 |
| Decision Date | 1999-02-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZETA MULTIZONE LOCKING NAIL SYSTEM 75523181 not registered Dead/Abandoned |
Howmedica Inc. 1998-07-22 |