U-Motion II™ 1203-6436-RB

GUDID 04719872160021

Ceramic femoral head trial, Delta, φ36mm, L, +5mm

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial

• Primary Device ID: 04719872160021
• NIH Device Record Key: c0cd9953-4ab0-49f4-8ffc-eca0305d4b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Motion II™
• Version Model Number: 1203-6436-RB
• Catalog Number: 1203-6436-RB
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: 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	04719872160021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103497

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

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

[04719872160021]

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: 2017-05-18

On-Brand Devices [U-Motion II™]

• 04719872178200: Cup impactor, 230mm
• 04719872178194: Cup reamer handle, offset
• 04719872177937: Alignment guide, 20 degree
• 04719872177920: Modular flex shaft
• 04719872177913: Cup reamer handle, offset
• 04719872177906: Cup reamer handle, straight, EZ clean
• 04719872174059: U-Motion II Case #1
• 04719872174042: Depth gauge
• 04719872174035: Screw forceps
• 04719872174028: Alignment rod
• 04719872174011: Alignment tower, supine
• 04719872174004: Alignment tower, lateral
• 04719872173991: Liner impactor, 40mm
• 04719872173984: Liner impactor, 36mm
• 04719872173977: Liner impactor, 32mm
• 04719872173960: Liner impactor, 28mm
• 04719872173953: Drill bit, 50mm
• 04719872173946: Drill bit, 35mm
• 04719872173939: Drill bit, 25mm
• 04719872173922: Drill bit, 15mm
• 04719872173915: U-Motion II Drill guide
• 04719872173908: Universal screw driver
• 04719872173892: Straight screw driver
• 04719872173885: Universal handle, long
• 04719872173878: Universal handle, offset
• 04719872173823: Cup impactor, 230mm
• 04719872162155: U-Motion II Acetabular liner trial, 20°, ID28mm, OD44mm
• 04719872162148: U-Motion II Acetabular liner trial, 20°, ID36mm, OD70mm
• 04719872162131: U-Motion II Acetabular liner trial, 20°, ID36mm, OD68mm
• 04719872162124: U-Motion II Acetabular liner trial, 20°, ID36mm, OD66mm
• 04719872162117: U-Motion II Acetabular liner trial, 20°, ID36mm, OD64mm
• 04719872162100: U-Motion II Acetabular liner trial, 20°, ID36mm, OD62mm
• 04719872162094: U-Motion II Acetabular liner trial, 20°, ID36mm, OD60mm
• 04719872162087: U-Motion II Acetabular liner trial, 20°, ID36mm, OD58mm
• 04719872162070: U-Motion II Acetabular liner trial, 20°, ID36mm, OD56mm
• 04719872162063: U-Motion II Acetabular liner trial, 20°, ID36mm, OD54mm
• 04719872162056: U-Motion II Acetabular liner trial, 20°, ID36mm, OD52mm
• 04719872162032: U-Motion II Acetabular liner trial, 20°, ID32mm, OD70mm
• 04719872162025: U-Motion II Acetabular liner trial, 20°, ID32mm, OD68mm
• 04719872162018: U-Motion II Acetabular liner trial, 20°, ID32mm, OD66mm
• 04719872162001: U-Motion II Acetabular liner trial, 20°, ID32mm, OD64mm
• 04719872161998: U-Motion II Acetabular liner trial, 20°, ID32mm, OD62mm
• 04719872161981: U-Motion II Acetabular liner trial, 20°, ID32mm, OD60mm
• 04719872161974: U-Motion II Acetabular liner trial, 20°, ID32mm, OD58mm
• 04719872161967: U-Motion II Acetabular liner trial, 20°, ID32mm, OD56mm
• 04719872161950: U-Motion II Acetabular liner trial, 20°, ID32mm, OD54mm
• 04719872161943: U-Motion II Acetabular liner trial, 20°, ID32mm, OD52mm
• 04719872161936: U-Motion II Acetabular liner trial, 20°, ID32mm, OD50mm
• 04719872161929: U-Motion II Acetabular liner trial, 20°, ID32mm, OD48mm
• 04719872161905: U-Motion II Acetabular liner trial, 20°, ID40mm, OD70mm