The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Cruciometer.
| Device ID | K884483 |
| 510k Number | K884483 |
| Device Name: | CRUCIOMETER |
| Classification | Spoon, Ear |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert R Moore |
| Correspondent | Robert R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | JZE |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1989-01-18 |