Conformity Stem 9110-6004

GUDID 04711605585385

Broach, #4

UNITED ORTHOPEDIC CORP.

Orthopaedic broach

• Primary Device ID: 04711605585385
• NIH Device Record Key: dcf0bb68-ebdd-4655-a70d-e8b536822b98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conformity Stem
• Version Model Number: 9110-6004
• Catalog Number: 9110-6004
• 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: +886 0229294567
• Email: service@uoc.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605585385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183312

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[04711605585385]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-12
• Device Publish Date: 2019-09-02

On-Brand Devices [Conformity Stem]

• 04711605586573: Neck trial, STD, 135°
• 04711605587105: Conformity sharp broach case, #1~#5
• 04711605587099: Conformity MIS case
• 04711605587082: Hip stem basic case
• 04711605587075: Conformity stem case
• 04711605586597: Neck trial, high offset, 135°
• 04711605585453: Broach, #11
• 04711605585446: Broach, #10
• 04711605585439: Broach, #9
• 04711605585422: Broach, #8
• 04711605585415: Broach, #7
• 04711605585408: Broach, #6
• 04711605585392: Broach, #5
• 04711605585385: Broach, #4
• 04711605585378: Broach, #3
• 04711605585361: Broach, #2
• 04711605585354: Broach, #1
• 04711605587587: Calcar reamer, large
• 04711605587570: Calcar reamer, small
• 04711605586177: Neck resection guide
• 04711605587112: Conformity sharp broach case, #6~#8
• 04719872145998: Stem extractor
• 04719872145592: Neck template
• 04719872145424: Dual offset broach handle, right
• 04719872145417: Dual offset broach handle, left
• 04719872145400: Offset broach handle
• 04719872145394: Straight broach handle
• 04719872144397: Canal sizer, Ø18mm
• 04719872144380: Canal sizer, Ø16mm
• 04719872144373: Canal sizer, Ø14mm
• 04719872144366: Canal sizer, Ø12mm
• 04719872144359: Canal sizer, Ø10mm
• 04719872144342: Canal sizer, Ø8mm
• 04719872144335: Restrictor inserter
• 04711605587976: Dual offset broach handle, right
• 04711605587969: Dual offset broach handle, left
• 04711605587952: Offset broach handle
• 04711605587945: Straight broach handle
• 04719872146049: Angled broach handle
• 04719872145585: Calcar reamer, large
• 04719872145301: Dual offset broach handle, left
• 04719872143277: Dual offset broach handle, right
• 04719872143260: Dual offset broach handle, left
• 04719872143147: Offset broach handle
• 04719872143130: Stem extractor, anterior
• 04719872142843: Smooth canal finder
• 04719872142393: Neck template
• 04719886894509: Calcar reamer, Ø35mm
• 04719886896176: Sharp broach, #11
• 04719886896169: Sharp broach, #10