The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Osseoscrew System.
| Device ID | K181980 |
| 510k Number | K181980 |
| Device Name: | OsseoScrew System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2018-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856051706 | K181980 | 000 |
| 00844856049116 | K181980 | 000 |
| 00844856049109 | K181980 | 000 |
| 00844856049093 | K181980 | 000 |
| 00844856049086 | K181980 | 000 |
| 00844856049079 | K181980 | 000 |
| 00844856049062 | K181980 | 000 |
| 00844856049055 | K181980 | 000 |
| 00844856049048 | K181980 | 000 |
| 00190376073095 | K181980 | 000 |
| 00844856049123 | K181980 | 000 |
| 00844856049130 | K181980 | 000 |
| 00844856049147 | K181980 | 000 |
| 00844856051676 | K181980 | 000 |
| 00844856051669 | K181980 | 000 |
| 00844856051652 | K181980 | 000 |
| 00844856051645 | K181980 | 000 |
| 00844856049192 | K181980 | 000 |
| 00844856049185 | K181980 | 000 |
| 00844856049178 | K181980 | 000 |
| 00844856049161 | K181980 | 000 |
| 00844856049154 | K181980 | 000 |
| 00844856051690 | K181980 | 000 |