The following data is part of a premarket notification filed by Depuy Acromed, Inc. with the FDA for Frontier Anterior Scoliosis System.
| Device ID | K012916 |
| 510k Number | K012916 |
| Device Name: | FRONTIER ANTERIOR SCOLIOSIS SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY ACROMED, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY ACROMED, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-30 |
| Decision Date | 2001-11-27 |
| Summary: | summary |