Spirit

GUDID 00811714030814

Spirit PEEK 08 x 23

RESPONSIVE ORTHOPEDICS LLC

Ligament bone anchor

• Primary Device ID: 00811714030814
• NIH Device Record Key: 67875d26-2eca-40a2-8d35-f28649e9ff0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirit
• Version Model Number: 90-RAC-310823
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811714030814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180573

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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: 2019-03-04
• Device Publish Date: 2019-02-01

On-Brand Devices [Spirit ]

• 00811714032368: Spirit Tap 10mm
• 00811714032351: Spirit Tap 9mm
• 00811714032344: Spirit Tap 8mm
• 00811714032337: Spirit Tap 7mm
• 00811714032405: Spirit Titanium Tray
• 00811714031682: Spirit PEEK Tray
• 00811714031675: Spirit Tap Handle
• 00811714031668: Spirit PEEK Guide Wire
• 00811714031651: Spirit PEEK Driver
• 00811714031613: Spirit PEEK Tap 10mm
• 00811714031606: Spirit PEEK Tap 9mm
• 00811714031590: Spirit PEEK Tap 8mm
• 00811714031583: Spirit PEEK Tap 7mm
• 00811714031026: Spirit PEEK 09 x 28
• 00811714030814: Spirit PEEK 08 x 23
• 00811714030654: Spirit PEEK 07 x 23