The following data is part of a premarket notification filed by Frontier Medical Devices, Inc. with the FDA for Ancora Llc Interbody Fusion Device.
| Device ID | K143228 |
| 510k Number | K143228 |
| Device Name: | Ancora LLC Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | FRONTIER MEDICAL DEVICES, INC. 512 FOURTH STREET Gwinn, MI 49841 |
| Contact | Eric Seaborg |
| Correspondent | Rich Jansen SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-02-26 |
| Summary: | summary |