Atec Posterior Navigation Disc Prep Instruments
ATEC Posterior Navigation Disc Prep Instruments are reusable surgical tools for discectomy, bony resection and implant-size selection during spinal surgery. They are designed for use with…
ATEC Posterior Navigation Disc Prep Instruments are reusable surgical tools for discectomy, bony resection and implant-size selection during spinal surgery. They are designed for use with the Medtronic StealthStation navigation system.
Disc-preparation instruments act on disc or bone, while navigated trials help select the size of Alphatec interbody fusion implants. The trials are procedural tools rather than permanently implanted spacers.
Listed Item
Post NAV Right-Bend CUP Curette, Size 2
Navigation and Preparation
The navigation workflow references rigid anatomy to CT, MR, fluoroscopic or digitized anatomical data. The instruments are supplied nonsterile and require cleaning and steam sterilization by the user before reuse.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232345 |
| Record published | 2024-04-20 |
| Record revised | 2026-05-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 6 to 14 mm; height 7 to 11 mm; length 22 mm; angle 5 to 15 °; outer diameter 6 to 10 mm |
| Distribution end date | 2026-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 244-17-000-10-N | Width 10 mm | In distribution |
| 244-05-07092205-N | Width 9 mm | In distribution |
| 244-14-400-02-N | In distribution | |
| 244-05-08092210-N | Length 22 mm | In distribution |
| 244-03-000-06-N | Width 6 mm | In distribution |
| 244-05-08092205-N | Height 8 mm | In distribution |
| 244-03-000-10-N | Width 10 mm | In distribution |
| 244-03-000-09-N | Width 9 mm | In distribution |
| 244-17-000-09-N | Width 9 mm | In distribution |
| 244-05-07092210-N | Height 7 mm | In distribution |
| 244-05-10092200-N | Height 10 mm | In distribution |
| 244-05-11092200-N | Width 9 mm | In distribution |
| 244-05-09092215-N | Height 9 mm | In distribution |
| 244-03-000-13-N | Width 13 mm | In distribution |
| 244-05-11092215-N | Height 11 mm | In distribution |
| 244-05-09092200-N | Width 9 mm | In distribution |
| 244-03-000-07-N | Width 7 mm | In distribution |
| 244-05-11092205-N | Angle 5 ° | In distribution |
| 244-11-000-10-N | Outer Diameter 10 mm | In distribution |
| 244-13-000-08-N | Width 8 mm | In distribution |
| 244-17-000-07-N | Width 7 mm | In distribution |
| 244-05-10092205-N | Length 22 mm | In distribution |
| 244-17-000-11-N | Width 11 mm | In distribution |
| 244-11-000-08-N | Outer Diameter 8 mm | In distribution |
| 244-03-000-12-N | Width 12 mm | In distribution |
| 244-11-000-06-N | Outer Diameter 6 mm | In distribution |
| 244-05-09092205-N | Height 9 mm | In distribution |
| 244-05-08092200-N | Height 8 mm | In distribution |
| 244-03-000-14-N | Width 14 mm | In distribution |
| 244-14-000-02-N | In distribution | |
| 244-05-09092210-N | Width 9 mm | In distribution |
| 244-17-000-13-N | Width 13 mm | In distribution |
| 244-05-08092215-N | Angle 15 ° | In distribution |
| 244-17-000-06-N | Width 6 mm | In distribution |
| 244-17-000-12-N | Width 12 mm | In distribution |
| 244-17-000-14-N | Width 14 mm | In distribution |
| 244-05-11092210-N | Length 22 mm | In distribution |
| 244-05-10092215-N | Width 9 mm | In distribution |
| 244-14-300-02-N | In distribution | |
| 244-14-020-02-N | In distribution | |
| 244-05-10092210-N | Angle 10 ° | In distribution |
| 244-03-000-08-N | Width 8 mm | In distribution |
| 244-05-07092200-N | Length 22 mm | In distribution |
| 244-17-000-08-N | Width 8 mm | In distribution |
| 244-03-000-11-N | Width 11 mm | In distribution |
| 244-13-000-06-N | Width 6 mm | In distribution |
| 244-05-07092215-N | Angle 15 ° | In distribution |
| 244-13-000-10-N | Width 10 mm | In distribution |
| 244-01-000-06-N | Width 6 mm | Withdrawn |
| 244-01-000-12-N | Width 12 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252597 | 2026-02-19 |
| K240951 | 2024-06-06 |
| K232345 | 2023-11-02 |
| K232044 | 2023-10-06 |
| K232413 | 2023-09-08 |
| K223765 | 2023-03-23 |
| K153603 | 2016-04-29 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 7 units |
| 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 15 units |
| 2022-09-14 | Class II | No Marketing Application | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. | 42 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.