GRAVITY

GUDID 00840420194602

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00840420194602
• NIH Device Record Key: 4fb707e7-2e34-467f-8304-8a0d12bc889b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAVITY
• Version Model Number: 86PPS1N0
• 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: true
• 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

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420194602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170889

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

[00840420194602]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-08

On-Brand Devices [GRAVITY]

• 00840420194619: 86PP00N0
• 00840420194602: 86PPS1N0
• 00840420194596: 86PP0006
• 00840420194589: 86PP0005
• 00840420194572: 86PP0004
• 00840420194565: 86PP0003
• 00840420194558: 86PP0002
• 00840420194541: 86PP0001
• 00840420193735: 86PKN255
• 00840420193728: 86PKN035
• 00840420193711: 86PK2027
• 00840420165961: 86TAN255
• 00840420165954: 86TAN035
• 00840420165947: 86TA2027
• 00889797103336: 86PP0004
• 00889797103329: 86PP0003
• 00889797103312: 86PP0006