The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Fortitude Cement Restrictor.
| Device ID | K021719 |
| 510k Number | K021719 |
| Device Name: | FORTITUDE CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Contact | David M Hooper |
| Correspondent | David M Hooper SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 Austin, TX 78727 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-08-15 |
| Summary: | summary |