U2 Hip Stem, Revision Hip Stem With Collar, Curved 1104-1316

GUDID 04712602340489

Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø16.5x230mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340489
NIH Device Record Key0b6fc387-2e44-4d62-968d-a4e8ca2a0192
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Hip Stem, Revision Hip Stem With Collar, Curved
Version Model Number1104-1316
Catalog Number1104-1316
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602340489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-02
Device Publish Date2015-10-24

On-Brand Devices [U2 Hip Stem, Revision Hip Stem With Collar, Curved]

04712602340564Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø18x230mm
04712602340557Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø16.5x230mm
04712602340540Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø15x230mm
04712602340533Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø14x230mm
04712602340526Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø13x230mm
04712602340519Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø12x230mm
04712602340502Revision hip stem, Ti plasma spray, With collar, Curved, Right, Ø11x230mm
04712602340496Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø18x230mm
04712602340489Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø16.5x230mm
04712602340472Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø15x230mm
04712602340465Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø14x230mm
04712602340458Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø13x230mm
04712602340441Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø12x230mm
04712602340434Revision hip stem, Ti plasma spray, With collar, Curved, Left, Ø11x230mm

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