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  |