Lightning 905000-0003

GUDID 00811714034416

Lightning Suture Anchor

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

• Primary Device ID: 00811714034416
• NIH Device Record Key: f7216c6d-70ac-42ae-a57d-304738a9da62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning
• Version Model Number: 905000-0003
• Catalog Number: 905000-0003
• 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	00811714034416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180951

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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [Lightning]

• 00811714030258: Lightning Probe Long
• 00811714030241: Lightning Probe Short
• 00811714030210: Lightning Guide Tube V-Mouth Short
• 00811714030203: Lightning Guide Tube Crown Short
• 00811714030173: Lightning Guide Tube V-Mouth Long
• 00811714030166: Lightning Guide Tube Crown Long
• 00811714030142: Lightning Drill Short
• 00811714030128: Lightning Drill Long
• 00811714030098: Lightning Suture Anchor Short
• 00811714030081: Lightning Suture Anchor Long
• 00811714034416: Lightning Suture Anchor
• 00811714034409: Lightning Suture Anchor
• 00811714034393: Lightning Suture Anchor
• 00811714034669: Lightning Standard Drill Long
• 00811714034652: Lightning Standard Drill Medium
• 00811714034645: Lightning Standard Drill Short
• 00811714034614: Lightning Blunt Probe
• 00811714034584: Lightning Trocar Probe Long
• 00811714034577: Lightning Trocar Probe Medium
• 00811714034560: Lightning Trocar Probe Short
• 00811714034539: 905003-0003
• 00811714034522: Lightning Guide Tube V-Mouth Medium
• 00811714034492: Lightning Guide Tube Crown Long
• 00811714034485: Lightning Guide Tube Crown Medium
• 00811714034478: Lightning Guide Tube Crown Short
• 00811714032702: Lightning Long Instrument Set
• 00811714032696: Lightning Medium Instrument Set
• 00811714032689: Lightning Short Instrument Set
• 00811714035826: Lightning Long Drill
• 00811714035512: Lightning Guide Tube V-Mouth Medium
• 00811714035505: Lightning Trocar Probe Medium
• 00811714035406: Lightning Standard Drill Medium
• 00811714035949: Lightning Trocar Probe Long - Packaged