ORTHOLOC

GUDID 00840420150677

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840420150677
• NIH Device Record Key: 39de2fc3-cdf1-4d61-9fd6-0e4b980f3604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOLOC
• Version Model Number: 58S34045
• 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: true
• 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
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420150677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102429

FDA Product Code

• HWC: Screw, fixation, bone

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: 2016-09-17

On-Brand Devices [ORTHOLOC]

• 00889797037150: 5362000014
• 00889797037143: 5362000012
• 00889797036535: 5272000014
• 00889797036429: 5202012024
• 00889797036351: 5202000002
• 00889797017862: 52022260
• 00889797017855: 52022230
• 00840420124494: 5361006002
• 00840420124487: 5361006001
• 00840420124470: 5361004002
• 00840420124463: 5361004001
• 00840420124456: 5361002000
• 00840420124449: 5201000504
• 00840420124432: 5201000503
• 00840420124425: 5201000306
• 00840420124418: 5201000304
• 00840420124401: 5201000303
• 00840420124395: 5201000206
• 00840420124388: 5201000204
• 00840420124371: 5201000100
• 00840420123732: 59240000
• 00840420117151: 4942045L
• 00840420117144: 4942040L
• 00840420117137: 4942035L
• 00840420117113: 4942050L
• 00840420116819: 4942028L
• 00840420116383: 4942030L
• 00840420116222: 4942014L
• 00840420116215: 4942010L
• 00840420116192: 4942012L
• 00840420116185: 4942026L
• 00840420116116: 4942024L
• 00840420116031: 4942016L
• 00840420116024: 4942020L
• 00840420116017: 4942022L
• 00840420116000: 4942018L
• 00840420115232: 58924022
• 00840420115225: 58924020
• 00840420115218: 58924018
• 00840420115201: 58924016
• 00840420115157: 58944024
• 00840420115140: 58944022
• 00840420115126: 58924028
• 00840420115102: 58944026
• 00840420115096: 58944028
• 00840420115072: 58944060
• 00840420115065: 58944030
• 00840420115058: 58934026
• 00840420115034: 58924024
• 00840420115027: 58924030