| Primary Device ID | 00190376541112 |
| NIH Device Record Key | aa14597a-4fb1-45b1-b773-5392012007d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valence Robotic Navigation System |
| Version Model Number | 525-17413-55-RJ |
| 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 |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376541112 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376541112]
Moist Heat or Steam Sterilization
[00190376541112]
Moist Heat or Steam Sterilization
[00190376541112]
Moist Heat or Steam Sterilization
[00190376541112]
Moist Heat or Steam Sterilization
[00190376541112]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
| 00190376647852 | Valence Robot Alpha Core Inst. M |
| 00190376647845 | Valence Robot Alpha Stimulating Inst. S |
| 00190376647838 | Valence Robot Alpha Stimulating Inst. M |
| 00190376647821 | Valence Robot Alpha Core Inst. S |
| 00190376643809 | Valence Robot Alpha Fixation Inst. |
| 00190376585659 | Slap Hammer, Small |
| 00190376560274 | Scalpel Handle, NM, Robot |
| 00190376560267 | Scalpel Handle, Robot |
| 00190376560250 | Tissue Protector, S Smooth, NM |
| 00190376560243 | Tissue Protector, S Teeth, NM |
| 00190376560236 | Tissue Protector, M Smooth, NM |
| 00190376560229 | Tissue Protector, M Teeth, NM |
| 00190376560212 | Open Reduction Screw Clip On |
| 00190376541440 | TP Dilator, S Conical Tip, Robot |
| 00190376541433 | TP Dilator, S Bullet Awl Tip, Robot |
| 00190376541402 | TP Dilator, M Conical Tip, Robot |
| 00190376541396 | TP Dilator, M Bullet Awl Tip, Robot |
| 00190376541372 | Tissue Protector, S Smooth |
| 00190376541365 | Tissue Protector, S Teeth |
| 00190376541358 | Tissue Protector, M Smooth |
| 00190376541341 | Tissue Protector, M Teeth |
| 00190376541334 | Awl Tap Cap |
| 00190376541327 | Awl, Robot |
| 00190376541310 | Insulating Sleeve, NM, Robot |
| 00190376541211 | 7.2mm Drill, Power, Robot |
| 00190376541204 | 7.2mm Drill, Robot |
| 00190376541198 | 6.9mm Drill, Power, Robot |
| 00190376541181 | 6.9mm Drill, Robot |
| 00190376541174 | 6.6mm Drill, Power, Robot |
| 00190376541167 | 6.6mm Drill, Robot |
| 00190376541150 | 6.2mm Drill, Power, Robot |
| 00190376541143 | 6.2mm Drill, Robot |
| 00190376541136 | 5.9mm Drill, Power, Robot |
| 00190376541129 | 5.9mm Drill, Robot |
| 00190376541112 | 5.5mm Drill, Power, Robot |
| 00190376541105 | 5.5mm Drill, Robot |
| 00190376541099 | 5.2mm Drill, Power, Robot |
| 00190376541082 | 5.2mm Drill, Robot |
| 00190376541075 | 4.8mm Drill, Power, Robot |
| 00190376541068 | 4.8mm Drill, Robot |
| 00190376541051 | 4.5mm Drill, Power, Robot |
| 00190376541044 | 4.5mm Drill, Robot |
| 00190376541037 | 4.1mm Drill, Power, Robot |
| 00190376541020 | 4.1mm Drill, Robot |
| 00190376541013 | 3.8mm Drill, Power, Robot |
| 00190376541006 | 3.8mm Drill, Robot |
| 00190376540993 | 3.5mm Drill, Power, Robot |
| 00190376540986 | 3.5mm Drill, Robot |
| 00190376540979 | 3.1mm Drill, Power, Robot |
| 00190376540962 | 3.1mm Drill, Robot |