UTF™ Stem 9106-5314

GUDID 04719872171225

UTF Neck trial, reduced standard, #13~#14

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872171225
• NIH Device Record Key: 6e9a5e51-50e4-48ef-923c-d953d6428fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTF™ Stem
• Version Model Number: 9106-5314
• Catalog Number: 9106-5314
• 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	04719872171225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132207

FDA Product Code

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

Sterilization

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

[04719872171225]

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: 2017-05-26

On-Brand Devices [UTF™ Stem]

• 04719872179139: UTF Stem case #1
• 04719872177777: Canal finder rasp
• 04719872172727: UTF Stem Case #3
• 04719872172703: UTF Stem case #2
• 04719872172680: UTF Stem, reduced, extractor
• 04719872172673: Sliding rod
• 04719872172666: Stem extractor wrench
• 04719872172659: Stem extractor
• 04719872172642: Hammer
• 04719872172635: Femoral cutting chisel
• 04719872172628: Femoral cutting chisel
• 04719872172611: Start reamer, reduced
• 04719872172604: Start reamer
• 04719872172598: Start reamer
• 04719872172581: Neck resection guide
• 04719872172574: Dual offset broach handle, right
• 04719872172567: Dual offset broach handle, left
• 04719872172550: UTF Stem, reduced, quick connect holder
• 04719872172543: Offset broach handle
• 04719872172536: UTF Stem, quick connect holder
• 04719872172529: Curved stem impactor
• 04719872172505: Curved stem impactor
• 04719872172499: Straight stem impactor
• 04719872172475: Straight stem impactor
• 04719872172468: Stem holder
• 04719872172451: Straight broach handle
• 04719872172444: Anteversion handle
• 04719872171294: UCP Neck trial, high offset
• 04719872171287: UCP Neck trial, standard
• 04719872171270: UTF Neck trial, reduced, high offset, #13~#14
• 04719872171263: UTF Neck trial, reduced, high offset, #9~#12
• 04719872171256: UTF Neck trial, reduced, high offset, #5~#8
• 04719872171249: UTF Neck trial, reduced, high offset, #1~#4
• 04719872171225: UTF Neck trial, reduced standard, #13~#14
• 04719872171218: UTF Neck trial, reduced, standard, #9~#12
• 04719872171201: UTF Neck trial, reduced, standard, #5~#8
• 04719872171195: UTF Neck trial, reduced, standard, #1~#4
• 04719872171171: UTF Neck trial, high offset, #16.5~#22
• 04719872171164: UTF Neck trial, high offset, #12~#14.5
• 04719872171157: UTF Neck trial, high offset, #7.5~#11
• 04719872171140: UTF Neck trial, standard, #16.5~#22
• 04719872171133: UTF Neck trial, standard, #12~#14.5
• 04719872167563: UTF Broach, reduced, #13
• 04719872167556: UTF Broach, reduced, #11
• 04719872167532: UTF Broach, reduced, #10
• 04719872167525: UTF Broach, reduced, #9
• 04719872167501: UTF Broach, reduced, #8
• 04719872167488: UTF Broach, reduced, #6
• 04719872167464: UTF Broach, reduced, #5
• 04719872167440: UTF Broach, reduced, #4