The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Biopin.
| Device ID | K982951 |
| 510k Number | K982951 |
| Device Name: | IMTEC BIOPIN |
| 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 | 1998-08-24 |
| Decision Date | 1999-06-21 |
| Summary: | summary |