The following data is part of a premarket notification filed by Nexmed, Inc. with the FDA for Nexmed Cancellous Bone Screws.
Device ID | K951656 |
510k Number | K951656 |
Device Name: | NEXMED CANCELLOUS BONE SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Contact | Rebecca H Wahl |
Correspondent | Rebecca H Wahl NEXMED, INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-10 |
Decision Date | 1995-07-18 |