Spirit PEEK Screw 900000-0923

GUDID 00811714033723

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714033723
• NIH Device Record Key: 796c3415-5924-45a5-bbdc-b19cecf3f747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirit PEEK Screw
• Version Model Number: 900000-0923
• Catalog Number: 900000-0923
• 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	00811714033723 [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: 2021-05-06
• Device Publish Date: 2021-04-28

On-Brand Devices [Spirit PEEK Screw]

• 00811714034164: 900000-1135
• 00811714034096: 900000-1128
• 00811714034041: 900000-1123
• 00811714034003: 900000-1035
• 00811714033938: 900000-1028
• 00811714033884: 900000-1023
• 00811714033846: 900000-0935
• 00811714033778: 900000-0928
• 00811714033723: 900000-0923
• 00811714033686: 900000-0835
• 00811714033617: 900000-0828
• 00811714033563: 900000-0823
• 00811714033525: 900000-0735
• 00811714033457: 900000-0728
• 00811714033402: 900000-0723