The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Fuson Bone Plug, Radiopaque.
| Device ID | K800142 |
| 510k Number | K800142 |
| Device Name: | FUSON BONE PLUG, RADIOPAQUE |
| Classification | Nail, Fixation, Bone |
| Applicant | ZIMMER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-21 |
| Decision Date | 1980-02-19 |