The following data is part of a premarket notification filed by Theken Surgical,llc with the FDA for Theken Cpod/lpod Vertebral Body Replacement System.
| Device ID | K032064 |
| 510k Number | K032064 |
| Device Name: | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | THEKEN SURGICAL,LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Contact | Tony Perry |
| Correspondent | Tony Perry THEKEN SURGICAL,LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-03 |
| Decision Date | 2004-02-20 |
| Summary: | summary |