510(k) K232345
- Device
- ATEC Posterior Navigated Disc Prep Instruments
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K232345
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-02
- Date received
- 2023-08-04
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Sandy Gill
- Address
- 1950 Camina Vida Roble Carlsbad CA US 92008 92008
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00190376528786 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376529004 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528984 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528977 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528960 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528861 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528854 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528847 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528830 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528823 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528816 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528809 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528793 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376529028 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528779 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528762 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528755 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528748 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528731 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528724 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528717 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528700 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528694 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528687 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376528670 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376529158 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376530055 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376530048 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376529295 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
| 00190376529288 | ATEC Posterior Navigation Disc Prep Instruments | ALPHATEC SPINE, INC. | 2024-04-20 |
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