AuRa 106-01-14

GUDID 10885862014115

Exactech, Inc.

Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis Revision uncoated femoral stem prosthesis

• Primary Device ID: 10885862014115
• NIH Device Record Key: 27dd9bd5-0c53-459b-b94c-4bff9da62fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuRa
• Version Model Number: 106-01-14
• Catalog Number: 106-01-14
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862014115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961304

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-11
• Device Publish Date: 2022-01-03

On-Brand Devices [AuRa]

• 10885862015563: AURA STEM EXTRACTOR
• 10885862015556: AURA CALCAR CUTTING JIG
• 10885862015549: AURA OSTEOTOMY GUIDE
• 10885862015358: AURA LG STEM REAMER SZ 5
• 10885862015341: AURA LG STEM REAMER SZ 4
• 10885862015334: AURA LG STEM REAMER SZ 3
• 10885862015327: AURA LG STEM REAMER SZ 2
• 10885862015310: AURA REAMER SZ 6
• 10885862015303: AURA REAMER SZ 5
• 10885862015297: AURA REAMER SZ 4
• 10885862015280: AURA REAMER SZ 3
• 10885862015273: AURA REAMER SZ 2
• 10885862015266: AURA REAMER SZ 1
• 10885862015259: AURA REAMER SZ 0
• 10885862015174: AURA PRIMARY BROACH SZ 6
• 10885862015167: AURA PRIMARY BROACH SZ 5
• 10885862015150: AURA PRIMARY BROACH SZ 4
• 10885862015143: AURA PRIMARY BROACH SZ 3
• 10885862015136: AURA PRIMARY BROACH SZ 2
• 10885862015129: AURA PRIMARY BROACH SZ 1
• 10885862015112: AURA PRIMARY BROACH SZ 0
• 10885862015242: AURA NECK TRIAL SZ 6
• 10885862015235: AURA NECK TRIAL SZ 2-5
• 10885862015228: AURA NECK TRIAL SZ 1
• 10885862015532: AURA LONG STEM TRIAL SZ 5, 300 MM
• 10885862015525: AURA LONG STEM TRIAL SZ 4, 300 MM
• 10885862015518: AURA LONG STEM TRIAL SZ 3, 300 MM
• 10885862015501: AURA LONG STEM TRIAL SZ 5, 250 MM
• 10885862015495: AURA LONG STEM TRIAL SZ 4, 250 MM
• 10885862015488: AURA LONG STEM TRIAL SZ 3, 250 MM
• 10885862015471: AURA LONG STEM TRIAL SZ 5, 200 MM
• 10885862015464: AURA LONG STEM TRIAL SZ 4, 200 MM
• 10885862015457: AURA LONG STEM TRIAL SZ 3, 200 MM
• 10885862015440: AURA LONG STEM TRIAL SZ 5, 165 MM
• 10885862015433: AURA LONG STEM TRIAL SZ 4, 165 MM
• 10885862015426: AURA LONG STEM TRIAL SZ 3, 165 MM
• 10885862015211: AURA LONG STEM BROACH SZ 5, 165MM
• 10885862015204: AURA LONG STEM BROACH SZ 4, 165MM
• 10885862015198: AURA LONG STEM BROACH SZ 3, 165MM
• 10885862015181: AURA LONG STEM BROACH SZ 2, 165MM