UKNEE™ 2401-2010

GUDID 04719872171362

Patellar trial, small

UNITED ORTHOPEDIC CORP.

Patella prosthesis trial

• Primary Device ID: 04719872171362
• NIH Device Record Key: 748e082e-b1b7-4fef-8bca-963815b0dc97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE™
• Version Model Number: 2401-2010
• Catalog Number: 2401-2010
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: true
• 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: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872171362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120507

FDA Product Code

• OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719872171362]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-06-21

On-Brand Devices [UKNEE™]

• 04719872175940: Caliper
• 04719872175933: Gap gauge, 9mm
• 04719872175926: Patellar sizing ring
• 04719872175902: Patellar drill guide , XL
• 04719872175896: Patellar drill guide , L
• 04719872175889: Patellar drill guide , M
• 04719872175872: Patellar drill guide , S
• 04719872175865: Screw driver
• 04719872175858: Patellar clamp ring, XL
• 04719872175841: Patellar clamp ring, L
• 04719872175834: Patellar clamp ring, M
• 04719872175827: Patellar clamp ring, S
• 04719872175810: Patellar resection clamp
• 04719872175803: Patellar drill
• 04719872175797: Patellar drill depth sleeve, XL
• 04719872175780: Patellar drill depth sleeve, L
• 04719872175773: Patellar drill depth sleeve, M
• 04719872175766: Patellar drill depth sleeve, S
• 04719872175759: Patellar reamer stopper
• 04719872175742: Patellar reamer , XL
• 04719872175735: Patellar reamer, L
• 04719872175728: Patellar reamer, M
• 04719872175711: Patellar reamer, S
• 04719872175704: Tibial IM rod, 430mm
• 04719872174219: T-handle
• 04719872174202: Stem trial driver
• 04719872174196: Bonefile
• 04719872174189: Notch cutting jig impactor
• 04719872174172: Spike retractor
• 04719872174165: Spike, long
• 04719872174158: Spike, short
• 04719872174141: Twist drill, Ø8mm
• 04719872174134: Femoral A/P chamfer guide handle
• 04719872174127: Extramedullary alignment tower
• 04719872174110: Resection Check Blade
• 04719872174103: Starter
• 04719872174097: Starter
• 04719872174080: T-handle assembly
• 04719872171393: Patellar trial, X-large
• 04719872171386: Patellar trial, large
• 04719872171379: Patellar trial, medium
• 04719872171362: Patellar trial, small
• 04719872157779: PS notch cutting jig, XL
• 04719872157762: Notch cutting jig , #5 , XL
• 04719872157755: PS notch cutting jig, L
• 04719872157748: Notch cutting jig , #4 , L
• 04719872157731: PS notch cutting jig, M
• 04719872157724: Notch cutting jig , #3 , M
• 04719872157717: PS notch cutting jig, S
• 04719872157700: Notch cutting jig , #2 , S