OrthAlign Plus 403001-07-US
GUDID 00810832031970
OrthAlign Plus Unit - P3 (US)
ORTHALIGN, INC.
Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system| Primary Device ID | 00810832031970 |
| NIH Device Record Key | 0198e4dd-8506-4f83-8f47-083f968cf2de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthAlign Plus |
| Version Model Number | 403001-07-US |
| Catalog Number | 403001-07-US |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com | |
| Phone | 866-582-0879 |
| CustomerService@orthalign.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810832031970 [Primary] |
FDA Product Code
| OLO | Orthopedic Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-03 |
| Device Publish Date | 2023-07-26 |
On-Brand Devices [OrthAlign Plus]
| 00810832030423 | HipAlign Inst Set: Universal Hip Set |
| 00810832030416 | HipAlign Inst Set: DA HipAlign Set w/ 90mm pins |
| 00810832030409 | HipAlign Inst Set: DA HipAlign Set |
| 00810832030379 | Fixation Pin, 4.0mm DIA x 90mm, 3.2mm Proximal End, 2-Pack, N/S |
| 00810832030362 | Universal Adapter, Clip, 17.6mm |
| 00810832030355 | Impactor, Straight, 4 Position, S/B |
| 00810832030348 | Impactor, Straight, 4 Position, S&N |
| 00810832030331 | Impactor, Straight, 4 Position, 1/4-28 DJO |
| 00810832030324 | Impactor, Straight, 4 Position, 7/16-20, DPY |
| 00810832030317 | Universal RS Adapter, Large- .485"-.750" |
| 00810832030300 | Universal RS Adapter, Small- .325"-.500" |
| 00810832030294 | Adapter,Implant,Off Impactr, M8x1.25, LIM |
| 00810832030287 | Implant Adapter, Magnetic, 9/16-7/8 |
| 00810832030270 | Implant Adapter, Magnetic, 3/8-1/2 |
| 00810832030249 | HIPALIGN INST. SET: DAA LL – Core Set |
| 00810832030188 | Impactor, Straight, Unibody, M10 x 1.5, MAX |
| 00810832030171 | Impactor, Straight, Unibody, 1/4-28, DJO |
| 00810832030164 | Impactor, Straight, Unibody, 3/8-32, WT |
| 00810832030157 | Impactor, Straight, Unibody, 5/16-24, ZIM |
| 00810832030140 | Impactor, Straight, Unibody, 3/8-16, S&N |
| 00810832030133 | Impactor, Straight, Unibody, 3/8-24, S/B |
| 00810832030126 | Impactor, Straight, Unibody, 7/16-20, DPY |
| 00810832030102 | Adapter,Implant,Str Impactr,M8x1.25,LIM |
| 00810832030096 | Impactor System Adapter, Lima |
| 00810832030089 | OrthAlign Plus Unit - Gap Balancing |
| 00810832030065 | Threaded Fixation Pin, 4.0 mm x 90mm, 3.2mm Proximal End |
| 00810832030041 | HIPALIGN INST. SET: DA/Supine Cup Placement |
| 00810832030034 | HIPALIGN INST. SET: DAA LL- Offset Impactor -03 Tray |
| 00810832030027 | HIPALIGN INST. SET: DAA LL- Straight Impactor -03 Tray |
| 00810832030010 | HIPALIGN INST. SET: DAA LL – US ONLY |
| 00810832030003 | KTIS Calibration Bracket |
| 00858704006992 | Adapter,Implant,Off Impactr,M10X1.5,MAXX |
| 00858704006985 | Adapter,Implant,Off Impactr,1/4-28,DJO |
| 00858704006978 | Adapter,Implant,Off Impactr,3/8-32,WT |
| 00858704006961 | Adapter,Implant,Off Impactr,3/8-16,S&N |
| 00858704006954 | Pin Driver, Tri-flat, Hudson Connector |
| 00858704006947 | Probe Mount, 60mm |
| 00858704006930 | Registration Probe |
| 00858704006923 | 5mm Trocar |
| 00858704006916 | Drill Guide, 140mm Cannula |
| 00858704006909 | Threaded Fixation Pin, 5MM X 170MM |
| 00858704006893 | Adapter,Implant,Str Impactr,1/4-28,DJO |
| 00858704006886 | Adapter,Implant,Str Impactr,M10x1.5,MAX |
| 00858704006879 | Adapter,Implant,Str Impactr,3/8-32,WT |
| 00858704006862 | Adapter,Implant,Str Impactr,3/8-16,S&N |
| 00858704006855 | Adapter,Implant,Str Impactr,7/16-20,DPY |
| 00858704006848 | Pin, Headless, Smooth, 65 mm |
| 00858704006831 | UniAlign, Midline Probe, Right |
| 00858704006824 | UniAlign Midline Probe, Left |
| 00858704006817 | UniAlign Tibial Jig Body |
Trademark Results [OrthAlign Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHALIGN PLUS 85919254 4474129 Live/Registered |
ORTHALIGN, INC. 2013-04-30 |
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