Mini Stealth All-Suture Anchor 911000-0001

GUDID 00811714035796

Mini Stealth All-Suture Anchor, with one #2 Suture

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 Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714035796
• NIH Device Record Key: 3e309ff3-cdd0-4ff3-9a93-d86a499870af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Stealth All-Suture Anchor
• Version Model Number: 911000-0001
• Catalog Number: 911000-0001
• 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	00811714035796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230094

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: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [Mini Stealth All-Suture Anchor]

• 00811714035796: Mini Stealth All-Suture Anchor, with one #2 Suture
• 00811714035802: Mini Stealth All-Suture Anchor, with two #2 Sutures