The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Plating System.
Device ID | K042695 |
510k Number | K042695 |
Device Name: | NCB PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Stephen H Mckelvey |
Correspondent | Stephen H Mckelvey ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-30 |
Decision Date | 2004-10-29 |
Summary: | summary |