UTS Hip Stem 9116-8113

GUDID 04719872142508

UTS Stem case, #3, left

UNITED ORTHOPEDIC CORP.

Instrument tray, reusable

• Primary Device ID: 04719872142508
• NIH Device Record Key: 4f4af310-e767-4ee1-9f25-084a22739993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTS Hip Stem
• Version Model Number: 9116-8113
• Catalog Number: 9116-8113
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	04719872142508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172251

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

[04719872142508]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [UTS Hip Stem]

• 04711605584531: UTS Calcar reamer, #00~#7
• 04711605584371: UTS Starter broach, #0~#00
• 04711605584159: Femoral alignment guide
• 04711605584142: Straight broach handle
• 04711605583787: Pusher
• 04711605583770: Modular T-handle
• 04711605583558: Alignment rod
• 04711605582933: UTS Stem, case #2
• 04711605582926: UTS Stem, case #1
• 04711605582421: UTS Stem case #3
• 04711605582414: UTS Stem, case #2
• 04711605582407: UTS Stem, case #1
• 04711605582391: UTS calcar reamer, #8~#14
• 04711605582384: UTS calcar reamer, #1~#7
• 04711605582377: UTS Neck trial, high offset, #12~#14
• 04711605582360: UTS Neck trial, high offset, #9~#11
• 04711605582353: UTS Neck trial, high offset, #5~#8
• 04711605582346: UTS Neck trial, high offset, #1~#4
• 04711605582339: UTS Neck trial, standard, #12~#14
• 04711605582322: UTS Neck trial, standard, #9~#11
• 04711605582315: UTS Neck trial, standard, #5~#8
• 04711605582308: UTS Neck trial, standard, #1~#4
• 04711605582292: UTS Neck trial, standard, #0~#00
• 04711605582285: Dual-offset broach handle, right
• 04711605582278: Dual-offset broach handle, left
• 04711605582261: Offset broach handle
• 04711605582254: UTS Start broach
• 04711605582247: Starter reamer
• 04711605582230: Femoral cutting chisel
• 04711605582223: UTS Neck resection guide
• 04711605582216: Femoral head extractor
• 04711605582209: UTS Broach, ML 0mm, #00
• 04711605582193: UTS Broach, ML 0mm, #0
• 04711605582186: UTS Broach, ML 0mm, #14
• 04711605582179: UTS Broach, ML 0mm, #13
• 04711605582162: UTS Broach, ML 0mm, #12
• 04711605582155: UTS Broach, ML 0mm, #11
• 04711605582148: UTS Broach, ML 0mm, #10
• 04711605582131: UTS Broach, ML 0mm, #9
• 04711605582124: UTS Broach, ML 0mm, #8
• 04711605582117: UTS Broach, ML 0mm, #7
• 04711605582100: UTS Broach, ML 0mm, #6
• 04711605582094: UTS Broach, ML 0mm, #5
• 04711605582087: UTS Broach, ML 0mm, #4
• 04711605582070: UTS Broach, ML 0mm, #3
• 04711605582063: UTS Broach, ML 0mm, #2
• 04711605582056: UTS Broach, ML 0mm, #1
• 04711605585347: Femoral head extractor
• 04719872140504: Offset broach handle
• 04719872142089: Angled broach handle