U-Motion™ 1203-2028

GUDID 04719872178989

Ceramic Femoral Head Trial, φ28mm, S

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial

• Primary Device ID: 04719872178989
• NIH Device Record Key: 8a4c141e-1dc8-452d-a2e3-dfb895e6964a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Motion™
• Version Model Number: 1203-2028
• Catalog Number: 1203-2028
• 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
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872178989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103497
• Premarket Notification: K123550

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

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

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

Moist Heat or Steam Sterilization

[04719872178989]

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: 2017-07-14

On-Brand Devices [U-Motion™]

• 04719872179221: Universal handle
• 04719872179030: Ceramic Femoral Head Trial, φ32mm, L
• 04719872179023: Ceramic Femoral Head Trial, φ28mm, L
• 04719872179016: Ceramic Femoral Head Trial, φ32mm, M
• 04719872179009: Ceramic Femoral Head Trial, φ28mm, M
• 04719872178996: Ceramic Femoral Head Trial, φ32mm, S
• 04719872178989: Ceramic Femoral Head Trial, φ28mm, S
• 04719872173861: Universal handle
• 04719872173748: Size plate, U-Motion
• 04719872173731: Liner impactor, 36mm
• 04719872173724: Liner impactor, 32mm
• 04719872173717: Liner impactor, 26mm
• 04719872173700: Femoral head impactor, 36mm
• 04719872173694: Ceramic head impactor, 36mm
• 04719872173687: Femoral head impactor, 32mm
• 04719872173670: Ceramic head impactor, 32mm
• 04719872173663: Femoral head impactor, 28mm
• 04719872173656: Ceramic head impactor, 28mm
• 04719872173649: Femoral head impactor, 26mm
• 04719872173632: Femoral head impactor, 22mm
• 04719872173588: Universal handle