The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Oti Bone Cement Plug.
| Device ID | K030608 |
| 510k Number | K030608 |
| Device Name: | OTI BONE CEMENT PLUG |
| Classification | Prosthesis, Hip, Cement Restrictor |
| 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 | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-06-12 |