The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Graftcage Acx.
| Device ID | K053080 |
| 510k Number | K053080 |
| Device Name: | GRAFTCAGE ACX |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2005-12-01 |
| Summary: | summary |