Restoration 6013-0913

GUDID 07613327017854

Hip Stem

Howmedica Osteonics Corp.

Press-fit femoral stem prosthesis

• Primary Device ID: 07613327017854
• NIH Device Record Key: f6cf524b-7ae0-48f1-ba6b-fd8a27efd9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restoration
• Version Model Number: 6013-0913
• Catalog Number: 6013-0913
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327017854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944836

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Restoration]

• 07613327140927: ADM Insert
• 07613327140903: ADM Insert
• 07613327140897: ADM Insert
• 07613327140880: ADM Insert
• 07613327140873: ADM Insert
• 07613327140866: ADM Insert
• 07613327140842: ADM Insert
• 07613327140828: ADM Insert
• 07613327140804: ADM Insert
• 07613327140781: ADM Insert
• 07613327037173: Plate Screw
• 07613327037166: Plate Screw
• 07613327037159: Plate Screw
• 07613327037142: Plate Screw
• 07613327037135: Plate Screw
• 07613327037128: Plate Screw
• 07613327037111: Plate Screw
• 07613327037104: Plate Screw
• 07613327037098: Plate Screw
• 07613327037081: Plate Screw
• 07613327019872: Acetabular Wedge Augment
• 07613327019865: Acetabular Wedge Augment
• 07613327019858: Acetabular Wedge Augment
• 07613327019841: Acetabular Wedge Augment
• 07613327019834: Acetabular Wedge Augment
• 07613327019827: Acetabular Wedge Augment
• 07613327019810: Acetabular Wedge Augment
• 07613327019803: Acetabular Wedge Augment
• 07613327019797: Acetabular Wedge Augment
• 07613327019780: Acetabular Wedge Augment
• 07613327019773: Acetabular Wedge Augment
• 07613327019766: Acetabular Wedge Augment
• 07613327019759: Acetabular Wedge Augment
• 07613327019742: Acetabular Wedge Augment
• 07613327019735: Acetabular Wedge Augment
• 07613327019728: Acetabular Wedge Augment
• 07613327019711: Acetabular Wedge Augment
• 07613327019704: Acetabular Wedge Augment
• 07613327019551: Hip Stem
• 07613327019544: Hip Stem
• 07613327019537: Hip Stem
• 07613327019520: Hip Stem
• 07613327019513: Hip Stem
• 07613327019506: Hip Stem
• 07613327019490: Hip Stem
• 07613327019483: Hip Stem
• 07613327019476: Hip Stem
• 07613327019469: Hip Stem
• 07613327019452: Hip Stem
• 07613327019445: Hip Stem