The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Endosteal Fixation Device.
| Device ID | K912640 |
| 510k Number | K912640 |
| Device Name: | CONCEPT ENDOSTEAL FIXATION DEVICE |
| Classification | Screw, Fixation, Bone |
| Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Contact | Penny C Rasmussen |
| Correspondent | Penny C Rasmussen CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1992-05-01 |