The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Bone Tac.
| Device ID | K973180 |
| 510k Number | K973180 |
| Device Name: | IMTEC BONE TAC |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | M. K. Patterson |
| Correspondent | M. K. Patterson IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-18 |
| Summary: | summary |