AccessGUDID - DEVICE: Restoration (07613327019117)

GUDID

Device Identifier (DI) Information

Brand Name: Restoration
Version or Model: 6524-1016L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6524-1016L
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327019117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Bowed Hip Stem - Left

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Revision coated hip femur prosthesis	A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

GMDN Preferred Term Name

GMDN Definition

Revision coated hip femur prosthesis

A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

FDA Product Code

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Product Code	Product Code Name
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983870	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Size: 10
Device Size Text, specify: Neck Length: 35.0 Millimeter
Device Size Text, specify: Taper Connection: C-TPR
Device Size Text, specify: Stem Length: 205.0 Millimeter

Device Record Status

Public Device Record Key: e9417810-09cd-4851-bb15-1023471c0667
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015