The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Elbow Prosthesis.
| Device ID | K861680 |
| 510k Number | K861680 |
| Device Name: | OSTEONICS ELBOW PROSTHESIS |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-01 |
| Decision Date | 1986-06-27 |