Primary Device ID | 00190376540948 |
NIH Device Record Key | 6600fdab-609d-4258-92a6-09810743c969 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Valence Robotic Navigation System |
Version Model Number | 525-17413-28 |
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 | 00190376540948 [Primary] |
OLO | Orthopedic stereotaxic instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00190376540948]
Moist Heat or Steam Sterilization
[00190376540948]
Moist Heat or Steam Sterilization
[00190376540948]
Moist Heat or Steam Sterilization
[00190376540948]
Moist Heat or Steam Sterilization
[00190376540948]
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 |