The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Oti Unicondular Interpositional Spacer.
| Device ID | K022779 |
| 510k Number | K022779 |
| Device Name: | OTI UNICONDULAR INTERPOSITIONAL SPACER |
| Classification | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) |
| Applicant | OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Contact | Sam Son |
| Correspondent | Sam Son OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Product Code | HSH |
| CFR Regulation Number | 888.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-22 |
| Decision Date | 2002-11-20 |