The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Titanium Mesh System.
| Device ID | K032371 |
| 510k Number | K032371 |
| Device Name: | TITANIUM MESH SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Kimberly L Pruitt |
| Correspondent | Kimberly L Pruitt ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-01 |
| Decision Date | 2004-02-12 |
| Summary: | summary |