Atec Lateral Navigation Disc Prep Instruments
The ATEC LIF NAV stimulating primary dilator is a surgical access instrument used during spine surgery. It can also help locate nerves during or after preparation and placement of…
The ATEC LIF NAV stimulating primary dilator is a surgical access instrument used during spine surgery. It can also help locate nerves during or after preparation and placement of intervertebral fusion cages and pedicle screw fixation devices. Its uses include open and percutaneous minimally invasive approaches.
The navigated instrument is designed for use with the Medtronic StealthStation System. Navigation references a rigid anatomical structure such as a vertebra against CT or MR models, fluoroscopic images or digitized anatomical landmarks.
Listed Item
LIF NAV Primary Dilator Stimulating, Sterile
Supply
This listed dilator is supplied sterile. ATEC lateral navigation instruments are offered in sterile packaged configurations as well as nonsterile configurations requiring cleaning and steam sterilization.
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) | K223765 |
| Record published | 2023-08-26 |
| Record revised | 2026-05-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 6 to 18 mm; length 65 mm; height 6 to 12 mm; angle 10 °; outer diameter 10 to 18 mm |
| Distribution end date | 2026-01-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 266-13-010-10-N | Width 10 mm | In distribution |
| 266-00-100-N | In distribution | |
| 267-12-000-18-N | In distribution | |
| 266-10-10186510-N | Angle 10 ° | In distribution |
| 266-10-08186500-N | Height 8 mm | In distribution |
| 266-13-010-08-N | Width 8 mm | In distribution |
| 266-10-12186510-N | Length 65 mm | In distribution |
| 267-15-000-10-N | In distribution | |
| 267-13-010-10-N | In distribution | |
| 266-15-000-10-N | Width 10 mm | In distribution |
| 266-13-020-10-N | Width 10 mm | In distribution |
| 266-10-06186500-N | Width 18 mm | In distribution |
| 266-10-08186510-N | Length 65 mm | In distribution |
| 267-10-08186510-N | In distribution | |
| 266-12-000-10-N | Outer Diameter 10 mm | In distribution |
| 266-12-000-18-N | Outer Diameter 18 mm | In distribution |
| 267-15-000-08-N | In distribution | |
| 266-00-210-N | In distribution | |
| 266-00-100-N-S | In distribution | |
| 267-10-06186510-N | In distribution | |
| 266-15-000-08-N | Width 8 mm | In distribution |
| 266-15-000-12-N | Width 12 mm | In distribution |
| 267-15-000-12-N | In distribution | |
| 266-00-300-N | In distribution | |
| 266-10-10186500-N | Height 10 mm | In distribution |
| 267-10-12186510-N | In distribution | |
| 267-10-10186510-N | In distribution | |
| 266-10-12186500-N | Length 65 mm | In distribution |
| 267-10-08186500-N | In distribution | |
| 267-12-000-10-N | In distribution | |
| 266-10-06186510-N | Angle 10 ° | In distribution |
| 266-13-020-08-N | Width 8 mm | In distribution |
| 266-15-000-06-N | Width 6 mm | In distribution |
| 267-15-000-14-N | In distribution | |
| 266-15-000-14-N | Width 14 mm | In distribution |
| 267-10-06186500-N | In distribution | |
| 266-01-000-14-N | Width 14 mm | Withdrawn |
| 266-01-000-10-N | Width 10 mm | Withdrawn |
| 267-01-000-10-N | Withdrawn | |
| 266-01-000-08-N | Width 8 mm | Withdrawn |
| 266-01-000-12-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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alphatec Spine, Inc. | 510(k) number | 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 7 units |
| Alphatec Spine, Inc. | 510(k) number | 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 15 units |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 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.