FDA.reportPublic FDA data

KneeAlign 2

Primary DI
00810832031376
Brand
KneeAlign 2
Company
Orthalign, Inc.
Model
133631-01
Catalog number
133631-01
Device description
KneeAlign 2 Unit
Published
2021-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103829000KNEEALIGN SYSTEMOrthalign, Inc.2011-04-04OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810832031376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810832031376008108320313768108320313760810832031376

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
Storage Environment Atmospheric Pressure60 KiloPascal101 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-582-0879CustomerService@orthalign.com

Regulatory Flags#

DUNS number
023266163
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858704006558OrthAlign Plus403008-01403008-012016-09-23
00810832032328Lantern4035974035792025-12-29
00810832032243Lantern4035794035792025-11-19
00810832032489Lantern502000-02502000-022025-12-12
00810832032182Lantern4053104053102025-12-09
00810832031994Lantern502000-01502000-012025-09-12
00810832032403Lantern4025644025642025-11-12
00810832032410Lantern4025654025652025-11-12
00810832032427Lantern4025664025662025-11-12
00810832032434Lantern4025674025672025-11-12
00810832032472Lantern4025704025702025-11-12
00810832031581Lantern Surgical Assistant (LSA)4025054025052023-01-31
00810832032007Lantern Surgical Assistant (LSA)405204-KA405204-KA2023-11-21
00810832031642Lantern Surgical Assistant402519-01402519-012023-09-01
00810832031659Lantern Surgical Assistant402519-02402519-022023-09-01
00810832031666Lantern Surgical Assistant402519-03402519-032023-09-01
00810832031673Lantern Surgical Assistant402519-04402519-042023-09-01
00810832031680Lantern Surgical Assistant402519-05402519-052023-09-01
00810832031697Lantern Surgical Assistant402519-06402519-062023-09-01
00810832031710Lantern Surgical Assistant402528-01402528-012023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
18257200140367NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140374NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140381NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140398NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140404NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140411NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140428NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140435NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140442NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140459NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140466NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140473NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140527FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140534FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140558FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140565FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140572FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140596FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140602FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140619FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140626FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140633FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140657FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17