The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Optimesh 500e Cement Restrictor.
| Device ID | K033953 |
| 510k Number | K033953 |
| Device Name: | OPTIMESH 500E CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082 |
| Contact | Pamela Snyder |
| Correspondent | Pamela Snyder SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-07-06 |
| Summary: | summary |