ATEC Posterior Navigated Disc Prep Instruments
510(k) K232345
ATEC Posterior Navigated Disc Prep Instruments is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K232345 on 2 Nov 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232345 | Date2 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K232345
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232345
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ATEC Posterior Navigation Disc Prep Instruments 244-01-000-06-N | 244-01-000-06-N | 00190376529158 | Width 6 mm | No longer on the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-01-000-12-N | 244-01-000-12-N | 00190376529189 | Width 12 mm | No longer on the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-06-N | 244-03-000-06-N | 00190376529219 | Width 6 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-07-N | 244-03-000-07-N | 00190376529226 | Width 7 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-08-N | 244-03-000-08-N | 00190376529233 | Width 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-09-N | 244-03-000-09-N | 00190376529240 | Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-10-N | 244-03-000-10-N | 00190376529257 | Width 10 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-11-N | 244-03-000-11-N | 00190376529264 | Width 11 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-12-N | 244-03-000-12-N | 00190376529271 | Width 12 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-13-N | 244-03-000-13-N | 00190376529288 | Width 13 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-03-000-14-N | 244-03-000-14-N | 00190376529295 | Width 14 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-07092200-N | 244-05-07092200-N | 00190376528670 | Length 22 mm; Height 7 mm; Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-07092205-N | 244-05-07092205-N | 00190376528687 | Width 9 mm; Height 7 mm; Length 22 mm; Angle 5 deg | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-07092210-N | 244-05-07092210-N | 00190376528694 | Height 7 mm; Width 9 mm; Length 22 mm; Angle 10 deg | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-07092215-N | 244-05-07092215-N | 00190376528700 | Angle 15 deg; Width 9 mm; Height 7 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-08092200-N | 244-05-08092200-N | 00190376528717 | Height 8 mm; Width 9 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-08092205-N | 244-05-08092205-N | 00190376528724 | Height 8 mm; Angle 5 deg; Length 22 mm; Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-08092210-N | 244-05-08092210-N | 00190376528731 | Length 22 mm; Width 9 mm; Angle 10 deg; Height 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-08092215-N | 244-05-08092215-N | 00190376528748 | Angle 15 deg; Length 22 mm; Width 9 mm; Height 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-09092200-N | 244-05-09092200-N | 00190376528755 | Width 9 mm; Height 9 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-09092205-N | 244-05-09092205-N | 00190376528762 | Height 9 mm; Angle 5 deg; Width 9 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-09092210-N | 244-05-09092210-N | 00190376528779 | Width 9 mm; Length 22 mm; Height 9 mm; Angle 10 deg | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-09092215-N | 244-05-09092215-N | 00190376528786 | Height 9 mm; Angle 15 deg; Length 22 mm; Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-10092200-N | 244-05-10092200-N | 00190376528793 | Height 10 mm; Width 9 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-10092205-N | 244-05-10092205-N | 00190376528809 | Length 22 mm; Angle 5 deg; Width 9 mm; Height 10 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-10092210-N | 244-05-10092210-N | 00190376528816 | Angle 10 deg; Height 10 mm; Length 22 mm; Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-10092215-N | 244-05-10092215-N | 00190376528823 | Width 9 mm; Height 10 mm; Length 22 mm; Angle 15 deg | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-11092200-N | 244-05-11092200-N | 00190376528830 | Width 9 mm; Length 22 mm; Height 11 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-11092205-N | 244-05-11092205-N | 00190376528847 | Angle 5 deg; Length 22 mm; Height 11 mm; Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-11092210-N | 244-05-11092210-N | 00190376528854 | Length 22 mm; Width 9 mm; Height 11 mm; Angle 10 deg | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-05-11092215-N | 244-05-11092215-N | 00190376528861 | Height 11 mm; Angle 15 deg; Width 9 mm; Length 22 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-11-000-06-N | 244-11-000-06-N | 00190376530048 | Outer Diameter 6 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-11-000-08-N | 244-11-000-08-N | 00190376530055 | Outer Diameter 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-11-000-10-N | 244-11-000-10-N | 00190376542560 | Outer Diameter 10 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-13-000-06-N | 244-13-000-06-N | 00190376528960 | Width 6 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-13-000-08-N | 244-13-000-08-N | 00190376528977 | Width 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-13-000-10-N | 244-13-000-10-N | 00190376528984 | Width 10 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-14-000-02-N | 244-14-000-02-N | 00190376529004 | — | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-14-020-02-N | 244-14-020-02-N | 00190376529028 | — | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-14-300-02-N | 244-14-300-02-N | 00190376529035 | — | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-14-400-02-N | 244-14-400-02-N | 00190376529042 | — | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-06-N | 244-17-000-06-N | 00190376529066 | Width 6 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-07-N | 244-17-000-07-N | 00190376529073 | Width 7 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-08-N | 244-17-000-08-N | 00190376529080 | Width 8 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-09-N | 244-17-000-09-N | 00190376529097 | Width 9 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-10-N | 244-17-000-10-N | 00190376529103 | Width 10 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-11-N | 244-17-000-11-N | 00190376529110 | Width 11 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-12-N | 244-17-000-12-N | 00190376529127 | Width 12 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-13-N | 244-17-000-13-N | 00190376529134 | Width 13 mm | On the market |
| ATEC Posterior Navigation Disc Prep Instruments 244-17-000-14-N | 244-17-000-14-N | 00190376529141 | Width 14 mm | On the market |
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