The following data is part of a premarket notification filed by Colmed, Ltd. with the FDA for Jacob Wirz Transfixation Pin.
| Device ID | K811209 |
| 510k Number | K811209 |
| Device Name: | JACOB WIRZ TRANSFIXATION PIN |
| Classification | Splint, Endodontic Stabilizing |
| Applicant | COLMED, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELS |
| CFR Regulation Number | 872.3890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-01 |
| Decision Date | 1981-06-16 |