OrthAlign Plus 403001
GUDID 00810832030089
OrthAlign Plus Unit - Gap Balancing
ORTHALIGN, INC.
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 00810832030089 |
| NIH Device Record Key | 99928c0e-a638-4340-8ae0-67f427c77e6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthAlign Plus |
| Version Model Number | 403001-06 |
| Catalog Number | 403001 |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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. |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810832030072 [Primary] |
| GS1 | 00810832030089 [Package] Contains: 00810832030072 Package: Case [5 Units] In Commercial Distribution |
FDA Product Code
| OLO | Orthopedic Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-06 |
| Device Publish Date | 2017-12-21 |
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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