| Primary Device ID | 00190376476162 |
| NIH Device Record Key | b656b9c8-1315-4b5d-9944-4f64d39de524 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC Lateral Navigation Instruments |
| Version Model Number | 266-01-000-08-N |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Width | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376476162 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
[00190376476162]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-26 |
| 00190376523439 | Alpha LIF Navigated Disc Prep |
| 00190376522906 | LIF NAV OSTEOTOME 14mm |
| 00190376509792 | LIF NAV, SHAVER 14mm |
| 00190376509785 | LIF NAV, SHAVER 12mm |
| 00190376509778 | LIF NAV, SHAVER 10mm |
| 00190376509761 | LIF NAV, SHAVER 8mm |
| 00190376509754 | LIF NAV, SHAVER 6mm |
| 00190376494692 | LIF NAV PRIMARY DILATOR |
| 00190376477107 | LIF NAV TRIAL 6 x 18 x 65 mm 10° |
| 00190376476353 | LIF NAV ENDPLATE SCRAPER 8mm |
| 00190376476339 | LIF NAV ENDPLATE SCRAPER SS 10mm |
| 00190376476322 | LIF NAV ENDPLATE SCRAPER SS 8mm |
| 00190376476292 | LIF NAV COBB 18mm |
| 00190376476285 | LIF NAV COBB 10mm |
| 00190376476254 | LIF NAV TRIAL 12 x 18 x 65 mm 10° |
| 00190376476247 | LIF NAV TRIAL 12 x 18 x 65 mm 0° |
| 00190376476230 | LIF NAV TRIAL 10 x 18 x 65 mm 10° |
| 00190376476223 | LIF NAV TRIAL 10 x 18 x 65 mm 0° |
| 00190376476216 | LIF NAV TRIAL 8 x 18 x 65 mm 10° |
| 00190376476209 | LIF NAV TRIAL 8 x 18 x 65 mm 0° |
| 00190376476193 | LIF NAV TRIAL 6 x 18 x 65 mm 0° |
| 00190376476186 | LIF NAV OSTEOTOME 12mm |
| 00190376476179 | LIF NAV OSTEOTOME 10mm |
| 00190376476162 | LIF NAV OSTEOTOME 8mm |
| 00190376476155 | LIF NAV PRIMARY DILATOR CANNULATED |
| 00190376476070 | LIF NAV ENDPLATE SCRAPER 10mm |