Spirit Titanium Screw 901000-0920

GUDID 00811714033051

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714033051
• NIH Device Record Key: 531945a9-b992-42d8-915e-4466c71a9af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirit Titanium Screw
• Version Model Number: 901000-0920
• Catalog Number: 901000-0920
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811714033051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180573

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2021-05-07
• Device Publish Date: 2021-04-29

On-Brand Devices [Spirit Titanium Screw]

• 00811714033310: 901000-1030
• 00811714033266: 901000-1025
• 00811714033211: 901000-1020
• 00811714033150: 901000-0930
• 00811714033105: 901000-0925
• 00811714033051: 901000-0920
• 00811714032993: 901000-0830
• 00811714032948: 901000-0825
• 00811714032894: 901000-0820
• 00811714032832: 901000-0730
• 00811714032788: 901000-0725
• 00811714032733: 901000-0720