The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Roper-tuke Elbow.
| Device ID | K873660 |
| 510k Number | K873660 |
| Device Name: | ROPER-TUKE ELBOW |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| 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 | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1988-01-06 |