The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Cancellous Fixation Screw & Washer For Use W/screw.
Device ID | K871037 |
510k Number | K871037 |
Device Name: | CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW |
Classification | Screw, Fixation, Bone |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Penny Rasmussen |
Correspondent | Penny Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-17 |
Decision Date | 1987-03-25 |