The following data is part of a premarket notification filed by Quantum Orthopedics with the FDA for Quantum Cement Restrictor.
| Device ID | K040276 |
| 510k Number | K040276 |
| Device Name: | QUANTUM CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | QUANTUM ORTHOPEDICS 11662 CORTE GUERA San Diego, CA 92128 |
| Contact | Jason Blain |
| Correspondent | Jason Blain QUANTUM ORTHOPEDICS 11662 CORTE GUERA San Diego, CA 92128 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-05 |
| Decision Date | 2004-04-30 |
| Summary: | summary |