The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Orbic* Spherical Alloy.
| Device ID | K812827 |
| 510k Number | K812827 |
| Device Name: | ORBIC* SPHERICAL ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-08 |
| Decision Date | 1981-11-16 |