The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Arena-c Ha Peek Cervical Intervertebral Body Fusion Device.
| Device ID | K142026 |
| 510k Number | K142026 |
| Device Name: | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith L May |
| Correspondent | Meredith L May SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2014-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361023173 | K142026 | 000 |
| 00190361021216 | K142026 | 000 |
| 00190361021209 | K142026 | 000 |
| 00190361021193 | K142026 | 000 |
| 00190361021186 | K142026 | 000 |
| 00190361021179 | K142026 | 000 |
| 00190361021162 | K142026 | 000 |
| 00190361021155 | K142026 | 000 |
| 00190361021148 | K142026 | 000 |
| 00190361021131 | K142026 | 000 |
| 00190361021124 | K142026 | 000 |
| 00190361021117 | K142026 | 000 |
| 00190361021100 | K142026 | 000 |
| 00190361021094 | K142026 | 000 |
| 00190361021087 | K142026 | 000 |
| 00190361021223 | K142026 | 000 |
| 00190361023029 | K142026 | 000 |
| 00190361023166 | K142026 | 000 |
| 00190361023159 | K142026 | 000 |
| 00190361023142 | K142026 | 000 |
| 00190361023135 | K142026 | 000 |
| 00190361023128 | K142026 | 000 |
| 00190361023111 | K142026 | 000 |
| 00190361023104 | K142026 | 000 |
| 00190361023098 | K142026 | 000 |
| 00190361023081 | K142026 | 000 |
| 00190361023074 | K142026 | 000 |
| 00190361023067 | K142026 | 000 |
| 00190361023050 | K142026 | 000 |
| 00190361023043 | K142026 | 000 |
| 00190361023036 | K142026 | 000 |
| 00190361021070 | K142026 | 000 |