The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Herbert/whipple Bone Screw System, Herbert/whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw.
| Device ID | K143165 |
| 510k Number | K143165 |
| Device Name: | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| Correspondent | Stephen H. Mckelvey Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-03-31 |
| Summary: | summary |