The following data is part of a premarket notification filed by Theken Surgical,llc with the FDA for Theken Reveal Vbr System.
| Device ID | K050058 |
| 510k Number | K050058 |
| Device Name: | THEKEN REVEAL VBR SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | THEKEN SURGICAL,LLC 283 E WATERLOO RD. Akron, OH 44319 |
| Contact | Randy Theken |
| Correspondent | Randy Theken 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 | 2005-01-11 |
| Decision Date | 2005-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981052089 | K050058 | 000 |
| 10889981051952 | K050058 | 000 |
| 10889981051945 | K050058 | 000 |
| 10889981051938 | K050058 | 000 |
| 10889981051921 | K050058 | 000 |
| 10889981051914 | K050058 | 000 |
| 10889981051907 | K050058 | 000 |
| 10889981051891 | K050058 | 000 |
| 10889981051884 | K050058 | 000 |
| 10889981051877 | K050058 | 000 |
| 10889981051860 | K050058 | 000 |
| 10889981051969 | K050058 | 000 |
| 10889981051976 | K050058 | 000 |
| 10889981052072 | K050058 | 000 |
| 10889981052065 | K050058 | 000 |
| 10889981052058 | K050058 | 000 |
| 10889981052041 | K050058 | 000 |
| 10889981052034 | K050058 | 000 |
| 10889981052027 | K050058 | 000 |
| 10889981052010 | K050058 | 000 |
| 10889981052003 | K050058 | 000 |
| 10889981051990 | K050058 | 000 |
| 10889981051983 | K050058 | 000 |
| 10889981051853 | K050058 | 000 |