KneeAlign 401629
GUDID 00858704006527
Resection Guide, 1.27mm Slot Width
ORTHALIGN, INC.
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 00858704006527 |
| NIH Device Record Key | ba165f5b-0361-4d17-892c-500a338342fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KneeAlign |
| Version Model Number | 401629 |
| Catalog Number | 401629 |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
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 |
Device Dimensions
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
| Width | 1.27 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858704006527 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
[00858704006527]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-10 |
| Device Publish Date | 2020-01-31 |
Devices Manufactured by ORTHALIGN, INC.
| 00810832032328 - Lantern | 2026-01-06 Adapter EMPHASYS Offset - Lantern Hip |
| 00810832032243 - Lantern | 2025-12-24 Adapter Clip, 17.6mm Tall |
| 00810832032489 - Lantern | 2025-12-22 Lantern Hip, Navigation Unit, Supine and Lateral |
| 00810832032182 - Lantern | 2025-12-17 LANTERN NAVIGATION UNIT BRACKET, LIGHTWEIGHT |
| 00810832031994 - Lantern | 2025-09-22 Packaged Assembly, Nav Unit, LSA Hip |
| 00810832032274 - Lantern | 2025-07-10 Alignment Shim, 1mm |
| 00810832032281 - Lantern | 2025-07-10 Alignment Shim, 2mm |
| 00810832032298 - Lantern | 2025-07-10 Alignment Shim, 3mm |
Trademark Results [KneeAlign]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KNEEALIGN 77556377 3848346 Live/Registered |
VITRUVIAN ORTHOPAEDICS, INC. 2008-08-26 |
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