OLYMPIA

GUDID 00840420189004

WRIGHT MEDICAL TECHNOLOGY, INC.

Shoulder glenoid fossa prosthesis trial

• Primary Device ID: 00840420189004
• NIH Device Record Key: 957f4104-3a64-4c26-9a5b-c5e1f5821685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OLYMPIA
• Version Model Number: 2870GK56
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: 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: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter
• Length: 56 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420189004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002683

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

[00840420189004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-17

On-Brand Devices [OLYMPIA]

• 00840420189721: 28703013
• 00840420189714: 28703012
• 00840420189745: 28703017
• 00840420189738: 28703014
• 00840420189707: 28703009
• 00840420189691: 28703008
• 00840420189684: 28703005
• 00840420189677: 28703004
• 00840420189660: 28703003
• 00840420189653: 28703002
• 00840420189646: 28703001
• 00840420189011: 2870GK60
• 00840420189004: 2870GK56
• 00840420188991: 2870GK52
• 00840420188984: 2870GK48
• 00840420188977: 2870GK44
• 00840420188960: 2870GK40
• 00840420188953: 2870GC60
• 00840420188946: 2870GC56
• 00840420188939: 2870GC52
• 00840420188922: 2870GC48
• 00840420188915: 2870GC44
• 00840420188908: 2870GC40