The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Zeta Multizone Locking Nail System.
Device ID | K982958 |
510k Number | K982958 |
Device Name: | ZETA MULTIZONE LOCKING NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Vivian Kelly |
Correspondent | Vivian Kelly 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 | 1998-08-24 |
Decision Date | 1998-11-20 |
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 |