The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Indus Anterior Cervical Plate System, Model Im3xxx.
| Device ID | K073232 |
| 510k Number | K073232 |
| Device Name: | INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915 |
| Contact | Thomas A Carlson |
| Correspondent | Thomas A Carlson SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-15 |
| Decision Date | 2008-02-20 |
| Summary: | summary |